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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06003309
Registration number
NCT06003309
Ethics application status
Date submitted
11/07/2023
Date registered
21/08/2023
Date last updated
1/03/2024
Titles & IDs
Public title
Frequency and E-field Enhancement of ITBS for Depression (FREED)
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Scientific title
Frequency and E-field Enhancement of ITBS for Depression (FREED)
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Secondary ID [1]
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807836
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Universal Trial Number (UTN)
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Trial acronym
FREED
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Transcranial Magnetic Stimulation (TMS) - Fully Individualized iTBS
Treatment: Devices - Transcranial Magnetic Stimulation (TMS) - targeted-iTBS
Treatment: Devices - Transcranial Magnetic Stimulation (TMS) - Standard-iTBS
Active Comparator: The fully individualized form of iTBS (BOTH the frequency and E-field targeting approaches) - In the Ind-iTBS, the coil placement and current amplitude will be provided using individualized E-field modeling and coordinate-based cortical targeting. The stimulation frequency will also be individualized according to EEG-derived TGC.
Active Comparator: iTBS individualized using E-field targeting only (targeted-iTBS) - In the targeted-iTBS, the coil placement and current amplitude will be provided using individualized E-field modeling and coordinate-based cortical targeting.
Active Comparator: Standard iTBS treatment (i.e., typical iTBS localized to the DLPFC using the Beam F3 method) - The standard iTBS will be delivered with the typical 5Hz/50Hz patterned frequencies used in the FDA-approved treatment protocol and stimulation will be delivered according to the Beam F3 targeting.
Treatment: Devices: Transcranial Magnetic Stimulation (TMS) - Fully Individualized iTBS
Repetitive transcranial magnetic stimulation (rTMS) is a safe and effective treatment for TRD that is increasingly being used in clinical practice across the world. It's mechanism of action is based on Farady Law of electromagnetic induction where the magnetic field produced by TMS coil induces electric field in the neurons. In the Ind-iTBS, the coil placement and current amplitude will be provided using individualized E-field modelling and coordinate-based cortical targeting. The stimulation frequency will also be individualized according to EEG-derived TGC.
Treatment: Devices: Transcranial Magnetic Stimulation (TMS) - targeted-iTBS
Repetitive transcranial magnetic stimulation (rTMS) is a safe and effective treatment for TRD that is increasingly being used in clinical practice across the world. It's mechanism of action is based on Farady Law of electromagnetic induction where the magnetic field produced by TMS coil induces electric field in the neurons. In the targeted-iTBS, the coil placement and current amplitude will be provided using individualized E-field modelling and coordinate-based cortical targeting.
Treatment: Devices: Transcranial Magnetic Stimulation (TMS) - Standard-iTBS
Repetitive transcranial magnetic stimulation (rTMS) is a safe and effective treatment for TRD that is increasingly being used in clinical practice across the world. It's mechanism of action is based on Farady Law of electromagnetic induction where the magnetic field produced by TMS coil induces electric field in the neurons. The standard iTBS will be delivered with the typical 5Hz/50Hz patterned frequencies used in the FDA approved treatment protocol and stimulation will be delivered according to the Beam F3 targeting.
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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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Change from pre-treatment in fronto-parietal theta connectivity at post-treatment
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Assessment method [1]
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Source-localized fronto-parietal theta connectivity will be calculated from resting EEG
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Timepoint [1]
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pre-treatment (within 24 hours prior to first treatment) and post-treatment (within 72 hours of final treatment)
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Eligibility
Key inclusion criteria
- Diagnosis of major depressive episode (MDE, in accordance with the Diagnostic and
Statistical Manual of Mental Disorders 5th edition (DSM-5), in the context of unipolar
major depressive disorder disorder.
- 18-80 years of age.
- Male or female.
- At least one failed antidepressant medication trial at level 3 in the Antidepressant
Treatment History Form: Short Form (ATHF-SF) classification.
- Montgomery-Asberg Depression Rating Scale (MADRS) Score of >19 (moderate - severe
depression).
- No increase or initiation of new antidepressant therapy in the four weeks prior to
screening.
- Demonstrated capacity to give informed consent.
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Minimum age
18
Years
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Maximum age
80
Years
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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.
- Medically unstable patients.
- Concomitant neurological disorder or a history of a seizure disorder.
- Patients who are pregnant or breastfeeding.
- Any psychotic disorder or current active psychotic symptoms.
- Patients who have intracranial implants, other medical device or condition deemed
unsafe for TMS.
- Contraindication to MRI scanning.
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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
Not Applicable
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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
31/08/2023
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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
1/04/2025
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Actual
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Sample size
Target
75
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Australian National University - Canberra
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Recruitment postcode(s) [1]
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2601 - Canberra
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of California, San Diego
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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National Institutes of Health (NIH)
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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
The investigators propose a randomized 3-arm double-blinded parallel experimental trial (20
sessions over 4 weeks) in 75 patients with TRD. The three arms include (1) the combination of
a fully Individualized form of intermittent Theta Burst Stimulation (iTBS) (using BOTH the
frequency and electric field (E-field) targeting approaches) (Ind-iTBS)), (2) iTBS
individualized using E-field targeting only (targeted-iTBS) and (3) Standard iTBS treatment
(i.e., typical iTBS localized to the dorsolateral prefrontal cortex (DLPFC) using the Beam F3
method). Electroencephalography (EEG) data will be collected at rest and during a working
memory task, at baseline, and at the end of treatment along with clinical assessments of
depression severity. The target engagement dependent variable of interest in these three arms
will be fronto-parietal theta connectivity measured through resting-state EEG. The
investigators hypothesize that stimulation with Ind-iTBS will lead to greater changes in
fronto-parietal theta connectivity than that produced with targeted-TBS and standard iTBS.
Aim: To evaluate the effects of two individualized forms of iTBS (i.e., using BOTH the
frequency and E-field individualization; Ind-iTBS) compared to iTBS individualized for
E-field targeting only (targeted-iTBS) and standard iTBS on fronto-parietal theta
connectivity. Hypotheses: (1) Ind-iTBS will lead to greater changes in fronto-parietal theta
connectivity compared to both targeted-iTBS and standard iTBS. (2) Ind-iTBS will also lead to
a greater reduction in depressive symptoms (as defined by the mean reduction in Montgomery
Åsberg Depression Rating Scale Scores (MADRS)) compared to both targeted-iTBS and standard
iTBS.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06003309
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Interventional Psychiatry
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Address
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Country
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Phone
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858-207-0938
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06003309
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