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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05788042
Registration number
NCT05788042
Ethics application status
Date submitted
21/02/2023
Date registered
28/03/2023
Titles & IDs
Public title
Trial of Enhanced Neurostimulation for Anorexia
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Scientific title
Randomised Controlled Trial of Neurostimulation for Symptoms of Anorexia Nervosa
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Secondary ID [1]
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2021-016
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Universal Trial Number (UTN)
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Trial acronym
TRENA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anorexia Nervosa
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Condition category
Condition code
Mental Health
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Eating disorders
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Diet and Nutrition
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - MagPro TMS device (ARTG: 204659)
Treatment: Devices - tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637)
Active comparator: Active transcranial Direct Current Stimulation (tDCS) - It will be given continuously for 30 minutes at 2 mA, twice daily (separated by \>=2 hours) over the first 4 weeks, and daily over the second 4 weeks of the 8 week acute treatment period (84 sessions total).
Sham comparator: Sham transcranial Direct Current Stimulation (tDCS) - It will involve an initial ramping up to 0.5 mA and then a ramp down to 0 mA for the remainder of each treatment. The same number of sessions as active tDCS will be administered.
Active comparator: Active Repetitive Transcranial Magnetic Stimulation (rTMS) - Active rTMS twice per day (separated by = 2 hours) over the first 4 weeks. Two sessions per day (separated by = 2 hours), given on 2 days each week for the following 4 weeks. The total number of rTMS sessions over the 8 week acute treatment period will be 56.
Sham comparator: Sham Repetitive Transcranial Magnetic Stimulation (rTMS) - Sham rTMS twice per day (separated by = 2 hours) over the first 4 weeks. Two sessions per day (separated by = 2 hours), given on 2 days each week for the following 4 weeks. The same number of sessions as active rTMS will be administered.
Treatment: Devices: MagPro TMS device (ARTG: 204659)
rTMS will be administered using a MagPro TMS device (ARTG: 204659) which is approved for its intended use in this trial. rTMS involves the application of transient magnetic pulses which induce small currents in the underlying cortex via the principal of electromagnetic induction. rTMS will be administered using a patterned frequency stimulus called intermittent theta-burst stimulation (iTBS).This form of rTMS was chosen because a recent large multicentre trial showed 3 minutes of iTBS attained the same therapeutic effect as 30 minutes of standard rTMS, leading to FDA approval for depression. Each treatment session will comprise an extended iTBS session, i.e., 6.6 mins, delivered at 100% resting motor threshold (RMT). It will be targeted to the left DLPFC (F3 using the 10-20 International EEG system), consistent with the prior RCT of rTMS for AN.
Treatment: Devices: tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637)
tDCS will be self-administered using the 1x1 tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637) with two saline-soaked sponge electrodes held in place on the scalp using the Soterix Ole-2 headband. The device is intended to treat different neurological and psychiatric disorders. tDCS involves the passing of weak electrical current through the brain via electrodes placed upon the scalp. The current modulates the resting membrane potential of stimulated neurons which causes changes in neuronal excitability. The anode will be placed over the left F3 (10-20 System) and the cathode over F4 (electrode sizes 5 x 5cm, 25cm2). This montage was chosen to target the left DLPFC, consistent with prior pilot studies of tDCS in AN.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Effectiveness - Eating Disorder Examination Questionnaire (EDE Q)
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Assessment method [1]
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Self-report instrument that measures eating disorder behaviors and attitudes. Eating Disorder Examination Questionnaire; 28-items; rating scale 0 - 6; Higher scores on the global scale and subscales indicate more problematic eating behaviours and attitudes.
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Timepoint [1]
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Change from baseline at 8 weeks
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Primary outcome [2]
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Acceptability
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Assessment method [2]
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Number of completed sessions for active tDCS and active rTMS in the acute 8 week RCT period.
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Timepoint [2]
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8 weeks
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Secondary outcome [1]
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Weight
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Assessment method [1]
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Change in Body Mass Index. Weight status in AN is considered a key determinant of remission from illness.
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Timepoint [1]
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Change from baseline at 4 weeks
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Secondary outcome [2]
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Weight
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Assessment method [2]
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Change in Body Mass Index. Weight status in AN is considered a key determinant of remission from illness.
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Timepoint [2]
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Change from baseline at 8 weeks
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Secondary outcome [3]
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Weight
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Assessment method [3]
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Change in Body Mass Index. Weight status in AN is considered a key determinant of remission from illness.
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Timepoint [3]
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Change from baseline at 20 weeks
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Secondary outcome [4]
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Mood - Montgomery Asberg Depression Rating Score (MADRS)
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Assessment method [4]
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Depressive symptomology is a common psychiatric comorbidity of AN and both tDCS and rTMS significantly improve mood symptoms. 10-items; rating scale 0- 6; Higher score indicates more severe depression.
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Timepoint [4]
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Change from baseline at 4 weeks
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Secondary outcome [5]
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Mood - Montgomery Asberg Depression Rating Score (MADRS)
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Assessment method [5]
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Depressive symptomology is a common psychiatric comorbidity of AN and both tDCS and rTMS significantly improve mood symptoms. 10-items; rating scale 0- 6; Higher score indicates more severe depression.
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Timepoint [5]
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Change from baseline at 8 weeks
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Secondary outcome [6]
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Mood - Montgomery Asberg Depression Rating Score (MADRS)
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Assessment method [6]
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Depressive symptomology is a common psychiatric comorbidity of AN and both tDCS and rTMS significantly improve mood symptoms. 10-items; rating scale 0- 6; Higher score indicates more severe depression.
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Timepoint [6]
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Change from baseline at 20 weeks
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Secondary outcome [7]
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Neurocognition - Trail Making Test parts A and B (TMT: attention and cognitive flexibility)
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Assessment method [7]
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Deficits in set shifting has been found to be common in people with AN.
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Timepoint [7]
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Change from baseline at 8 weeks
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Secondary outcome [8]
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Neurocognition - Trail Making Test parts A and B (TMT: attention and cognitive flexibility)
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Assessment method [8]
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Deficits in set shifting has been found to be common in people with AN.
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Timepoint [8]
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Change from baseline at 20 weeks
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Secondary outcome [9]
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Neurocognition - Embedded Figures Test (EFT: field dependence vs independence).
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Assessment method [9]
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This task assesses central coherence, or the degree of focus on details in processing information. Poor central coherence is a potential etiologic or maintaining factor for people with eating disorders.
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Timepoint [9]
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Change from baseline at 8 weeks
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Secondary outcome [10]
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Neurocognition - Embedded Figures Test (EFT: field dependence vs independence).
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Assessment method [10]
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This task assesses central coherence, or the degree of focus on details in processing information. Poor central coherence is a potential etiologic or maintaining factor for people with eating disorders.
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Timepoint [10]
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Change from baseline at 20 weeks
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Secondary outcome [11]
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Neurocognition - STROOP Colour Word Test (response inhibition).
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Assessment method [11]
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The STROOP task assesses inhibitory control, which has been shown to be reduced in people with eating disorders.
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Timepoint [11]
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Change from baseline at 8 weeks
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Secondary outcome [12]
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Neurocognition - STROOP Colour Word Test (response inhibition).
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Assessment method [12]
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The STROOP task assesses inhibitory control, which has been shown to be reduced in people with eating disorders.
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Timepoint [12]
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Change from baseline at 20 weeks
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Secondary outcome [13]
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Neurocognition - Wisconsin Card Sorting Test (WSCT: perseveration).
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Assessment method [13]
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This task has been found to be sensitive to set shifting deficits in people with AN.
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Timepoint [13]
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Change from baseline at 8 weeks
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Secondary outcome [14]
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Neurocognition - Wisconsin Card Sorting Test (WSCT: perseveration).
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Assessment method [14]
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This task has been found to be sensitive to set shifting deficits in people with AN.
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Timepoint [14]
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Change from baseline at 20 weeks
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Secondary outcome [15]
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Psychological Symptoms - Depression Anxiety and Stress Scale (DASS-21)
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Assessment method [15]
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Self reported questionnaire designed to measure the severity of a range of symptoms common to both Depression and Anxiety. 21-items; rating scale 0- 3; Higher scores on subscales indicate more severe depression, anxiety and stress.
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Timepoint [15]
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Change from baseline at 8 weeks
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Secondary outcome [16]
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Psychological Symptoms - Depression Anxiety and Stress Scale (DASS-21)
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Assessment method [16]
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Self reported questionnaire designed to measure the severity of a range of symptoms common to both Depression and Anxiety. 21-items; rating scale 0- 3; Higher scores on subscales indicate more severe depression, anxiety and stress.
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Timepoint [16]
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Change from baseline at 20 weeks
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Secondary outcome [17]
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Functioning - The Assessment of Quality of Life Instrument (AQoL-4D)
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Assessment method [17]
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Measures quality of life for independent living, mental health, relationships, and senses. It as chosen as measures can be used for economic evaluation based on Quality Adjusted Life Years (QALYs). 12-items; scale 1-4; Higher score indicates lower health-related quality of life.
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Timepoint [17]
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Change from baseline at 8 weeks
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Secondary outcome [18]
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Functioning - The Assessment of Quality of Life Instrument (AQoL-4D)
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Assessment method [18]
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Measures quality of life for independent living, mental health, relationships, and senses. It as chosen as measures can be used for economic evaluation based on Quality Adjusted Life Years (QALYs). 12-items; scale 1-4; Higher score indicates lower health-related quality of life.
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Timepoint [18]
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Change from baseline at 20 weeks
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Secondary outcome [19]
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Change in Circumplex Scales of Interpersonal Efficacy (CSIE-32)
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Assessment method [19]
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Change in Circumplex Scales of Interpersonal Efficacy: 32-items; scale 0-10; Higher score indicate confidence that one can engage in variety of interpersonal behaviours.
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Timepoint [19]
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Change from baseline at 8 weeks
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Secondary outcome [20]
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Change in Circumplex Scales of Interpersonal Efficacy (CSIE-32)
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Assessment method [20]
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Change in Circumplex Scales of Interpersonal Efficacy: 32-items; scale 0-10; Higher score indicate confidence that one can engage in variety of interpersonal behaviours.
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Timepoint [20]
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Change from baseline at 20 weeks
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Secondary outcome [21]
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Total cost of costs of rTMS and tDCS administration
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Assessment method [21]
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Total cost of costs of rTMS and tDCS administration
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Timepoint [21]
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Through study completion, an average of 20 weeks
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Secondary outcome [22]
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Duration of inpatient hospital stay as recorded by clinical staff
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Assessment method [22]
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Duration of inpatient hospital stay as recorded by clinical staff
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Timepoint [22]
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Through study completion, an average of 20 weeks
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Secondary outcome [23]
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Number of re-admissions as reported by clinical staff.
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Assessment method [23]
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Number of re-admissions as reported by clinical staff
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Timepoint [23]
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From date of randomization until the date of study completion, assessed up to 20 weeks.
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Secondary outcome [24]
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Number of psychology sessions
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Assessment method [24]
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Number of psychology sessions
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Timepoint [24]
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Through study completion, an average of 20 weeks
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Secondary outcome [25]
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Cost of psychology sessions
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Assessment method [25]
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Cost of psychology sessions in $ AUD
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Timepoint [25]
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Through study completion, an average of 20 weeks
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Eligibility
Key inclusion criteria
* Aged =16 years,
* A current Diagnostic and Statistical Manual of Mental Disorders (5th edition DSM-5) diagnosis of anorexia nervosa
* Willing and able to participate and comply with study requirements
* Worked or studied in a context requiring some proficiency in spoken English (to ensure validity of neuropsychological testing)
* Under ongoing care by his/her own treating psychiatrist (to ensure patient safety during the study)
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Inability to provide informed consent
* Contraindications to tDCS/rTMS
* Failed to respond to an adequate course or rTMS (4 weeks) within the current illness course
* Had ECT in the last 3 months
* MoCA score of <26
* Significant risk of significant self harm or suicide as assessed by study psychiatrist(s)
* Currently enrolled in another interventional clinical trial or using an investigational device/product
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/08/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2025
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Actual
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Sample size
Target
70
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Northside Clinic - Sydney
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Recruitment postcode(s) [1]
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2031 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
The George Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The University of New South Wales
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Preliminary open-label studies have suggested that non-invasive brain stimulation methods of both transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) have clinical benefits for improving psychological and eating disorder related symptoms, which can persist at long-term follow ups after acute treatment (i.e., at 6 and 12 months). Here the investigators propose to conduct the first double-blinded, randomised sham-controlled study to directly compare the therapeutic effectiveness and acceptability of both treatment modalities. Participants will be recruited and treated at one inpatient setting (Northside Clinic, St Leonards, Sydney). This facility is one of the largest specialist eating disorder settings in Australia with approximately 130 new admissions every year (2019 data). All participants who give consent and who fulfill the eligibility criteria will be randomised to receive active tDCS, sham (placebo) tDCS, active rTMS or sham rTMS over 8 weeks. Trial participants, their treating psychiatrist, ward staff, and a study staff member (who will conduct blinded assessments of mood secondary outcome measures) will be blinded after assignment to intervention until the database is locked and the primary analysis completed. All participants will complete assessments of eating disorder symptoms, mood, psychological symptoms, neurocognition and functioning at baseline, end of week 4, 8 and 20. Expected outcomes include data on the relative effectiveness and acceptability for both treatment modalities in the inpatient and at-home setting (i.e., for at-home tDCS). The investigators expect that both active treatment arms will produce clinical benefits and have high acceptability, and that clinical benefits will be maintained with long-term at-home tDCS continuation treatment. These outcomes have potential to assist in reducing hospital stay and emergency re-admissions and improving day to day functioning in participants. Health economic data for both treatment modalities will additionally have utility from a service perspective, given the disparity in resource requirements between the two treatments (TMS, tDCS) in terms of costs for patients and access to treatment for people living in remote and rural areas (i.e., for at-home tDCS).
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Trial website
https://clinicaltrials.gov/study/NCT05788042
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Trial related presentations / publications
Aardoom JJ, Dingemans AE, Slof Op't Landt MC, Van Furth EF. Norms and discriminative validity of the Eating Disorder Examination Questionnaire (EDE-Q). Eat Behav. 2012 Dec;13(4):305-9. doi: 10.1016/j.eatbeh.2012.09.002. Epub 2012 Sep 19. First MB. Diagnostic and statistical manual of mental disorders, 5th edition, and clinical utility. J Nerv Ment Dis. 2013 Sep;201(9):727-9. doi: 10.1097/NMD.0b013e3182a2168a. No abstract available. Alonzo A, Fong J, Ball N, Martin D, Chand N, Loo C. Pilot trial of home-administered transcranial direct current stimulation for the treatment of depression. J Affect Disord. 2019 Jun 1;252:475-483. doi: 10.1016/j.jad.2019.04.041. Epub 2019 Apr 10. Arcelus J, Mitchell AJ, Wales J, Nielsen S. Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies. Arch Gen Psychiatry. 2011 Jul;68(7):724-31. doi: 10.1001/archgenpsychiatry.2011.74. Berryhill ME, Martin D. Cognitive Effects of Transcranial Direct Current Stimulation in Healthy and Clinical Populations: An Overview. J ECT. 2018 Sep;34(3):e25-e35. doi: 10.1097/YCT.0000000000000534. Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26. Erratum In: Lancet. 2018 Jun 23;391(10139):e24. doi: 10.1016/S0140-6736(18)31323-0. Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7. Couturier J, Lock J. What is remission in adolescent anorexia nervosa? A review of various conceptualizations and quantitative analysis. Int J Eat Disord. 2006 Apr;39(3):175-83. doi: 10.1002/eat.20224. Dalton B, Bartholdy S, McClelland J, Kekic M, Rennalls SJ, Werthmann J, Carter B, O'Daly OG, Campbell IC, David AS, Glennon D, Kern N, Schmidt U. Randomised controlled feasibility trial of real versus sham repetitive transcranial magnetic stimulation treatment in adults with severe and enduring anorexia nervosa: the TIARA study. BMJ Open. 2018 Jul 16;8(7):e021531. doi: 10.1136/bmjopen-2018-021531. Dedoncker J, Brunoni AR, Baeken C, Vanderhasselt MA. A Systematic Review and Meta-Analysis of the Effects of Transcranial Direct Current Stimulation (tDCS) Over the Dorsolateral Prefrontal Cortex in Healthy and Neuropsychiatric Samples: Influence of Stimulation Parameters. Brain Stimul. 2016 Jul-Aug;9(4):501-17. doi: 10.1016/j.brs.2016.04.006. Epub 2016 Apr 12. Fairburn, G.G. Cognitive Behavior Therapy and Eating Disorders. Guilford Press, New York, 2008. Garber AK, Sawyer SM, Golden NH, Guarda AS, Katzman DK, Kohn MR, Le Grange D, Madden S, Whitelaw M, Redgrave GW. A systematic review of approaches to refeeding in patients with anorexia nervosa. Int J Eat Disord. 2016 Mar;49(3):293-310. doi: 10.1002/eat.22482. Epub 2015 Dec 12. Hatch A, Madden S, Kohn M, Clarke S, Touyz S, Williams LM. Anorexia nervosa: towards an integrative neuroscience model. Eur Eat Disord Rev. 2010 May;18(3):165-79. doi: 10.1002/erv.974. Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033. Katzman DK. Medical complications in adolescents with anorexia nervosa: a review of the literature. Int J Eat Disord. 2005;37 Suppl:S52-9; discussion S87-9. doi: 10.1002/eat.20118. Khedr EM, Elfetoh NA, Ali AM, Noamany M. Anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex improves anorexia nervosa: A pilot study. Restor Neurol Neurosci. 2014;32(6):789-97. doi: 10.3233/RNN-140392. Knyahnytska YO, Blumberger DM, Daskalakis ZJ, Zomorrodi R, Kaplan AS. Insula H-coil deep transcranial magnetic stimulation in severe and enduring anorexia nervosa (SE-AN): a pilot study. Neuropsychiatr Dis Treat. 2019 Aug 6;15:2247-2256. doi: 10.2147/NDT.S207630. eCollection 2019. Lewinsohn PM, Striegel-Moore RH, Seeley JR. Epidemiology and natural course of eating disorders in young women from adolescence to young adulthood. J Am Acad Child Adolesc Psychiatry. 2000 Oct;39(10):1284-92. doi: 10.1097/00004583-200010000-00016. Liu A, Voroslakos M, Kronberg G, Henin S, Krause MR, Huang Y, Opitz A, Mehta A, Pack CC, Krekelberg B, Berenyi A, Parra LC, Melloni L, Devinsky O, Buzsaki G. Immediate neurophysiological effects of transcranial electrical stimulation. Nat Commun. 2018 Nov 30;9(1):5092. doi: 10.1038/s41467-018-07233-7. Loo CK, Martin DM, Alonzo A, Gandevia S, Mitchell PB, Sachdev P. Avoiding skin burns with transcranial direct current stimulation: preliminary considerations. Int J Neuropsychopharmacol. 2011 Apr;14(3):425-6. doi: 10.1017/S1461145710001197. Epub 2010 Oct 6. No abstract available. Lovibond, S.H. & Lovibond, P.F. (1995). Manual for the Depression Anxiety Stress Scales. (2nd. Ed.) Sydney: Psychology Foundation. Madden, S. (2015). Biopsychiatric theories of eating disorders. In The Wiley Handbook of Eating Disorders. Assessment, Prevention, Treatment, Policy, and Future Directions, Eds. Smolak, L., and Levine, M.P. Martin DM, McClintock SM, Forster JJ, Lo TY, Loo CK. Cognitive enhancing effects of rTMS administered to the prefrontal cortex in patients with depression: A systematic review and meta-analysis of individual task effects. Depress Anxiety. 2017 Nov;34(11):1029-1039. doi: 10.1002/da.22658. Epub 2017 May 24. McClelland J, Kekic M, Campbell IC, Schmidt U. Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Enduring Anorexia Nervosa: A Case Series. Eur Eat Disord Rev. 2016 Mar;24(2):157-63. doi: 10.1002/erv.2414. Epub 2015 Nov 4. McClintock SM, Reti IM, Carpenter LL, McDonald WM, Dubin M, Taylor SF, Cook IA, O'Reardon J, Husain MM, Wall C, Krystal AD, Sampson SM, Morales O, Nelson BG, Latoussakis V, George MS, Lisanby SH; National Network of Depression Centers rTMS Task Group; American Psychiatric Association Council on Research Task Force on Novel Biomarkers and Treatments. Consensus Recommendations for the Clinical Application of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Depression. J Clin Psychiatry. 2018 Jan/Feb;79(1):16cs10905. doi: 10.4088/JCP.16cs10905. Moffa AH, Martin D, Alonzo A, Bennabi D, Blumberger DM, Bensenor IM, Daskalakis Z, Fregni F, Haffen E, Lisanby SH, Padberg F, Palm U, Razza LB, Sampaio-Jr B, Loo C, Brunoni AR. Efficacy and acceptability of transcranial direct current stimulation (tDCS) for major depressive disorder: An individual patient data meta-analysis. Prog Neuropsychopharmacol Biol Psychiatry. 2020 Apr 20;99:109836. doi: 10.1016/j.pnpbp.2019.109836. Epub 2019 Dec 16. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382. Murray SB, Loeb KL, Le Grange D. Treatment outcome reporting in anorexia nervosa: time for a paradigm shift? 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Aust N Z J Psychiatry. 2006 Feb;40(2):121-8. doi: 10.1080/j.1440-1614.2006.01758.x. Wassermann EM. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Electroencephalogr Clin Neurophysiol. 1998 Jan;108(1):1-16. doi: 10.1016/s0168-5597(97)00096-8. Westwood H, Stahl D, Mandy W, Tchanturia K. The set-shifting profiles of anorexia nervosa and autism spectrum disorder using the Wisconsin Card Sorting Test: a systematic review and meta-analysis. Psychol Med. 2016 Jul;46(9):1809-27. doi: 10.1017/S0033291716000581. Epub 2016 Apr 25. Wu M, Giel KE, Skunde M, Schag K, Rudofsky G, de Zwaan M, Zipfel S, Herzog W, Friederich HC. Inhibitory control and decision making under risk in bulimia nervosa and binge-eating disorder. Int J Eat Disord. 2013 Nov;46(7):721-8. doi: 10.1002/eat.22143. Epub 2013 Jun 3.
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Contacts
Principal investigator
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Sloane Madden, Assoc. Prof.
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University of Sydney, Ramsay Health Care
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Donel Martin, Dr
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02 9382 8353
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All de-identified data though with ethics approval and data transfer agreements required
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Results publications and other study-related documents
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https://clinicaltrials.gov/study/NCT05788042