Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001253796
Ethics application status
Approved
Date submitted
9/09/2022
Date registered
19/09/2022
Date last updated
19/09/2022
Date data sharing statement initially provided
19/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the effect of new brain stimulation techniques on cognitive functioning.
Scientific title
Exploring the Effect of Novel Non-Invasive Neuromodulation Techniques on Cognitive Functioning in Healthy Adults - A pilot double-blinded randomised controlled trial.
Secondary ID [1] 307955 0
None
Universal Trial Number (UTN)
U1111-1282-3839
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognition 327611 0
Condition category
Condition code
Neurological 324697 324697 0 0
Studies of the normal brain and nervous system
Mental Health 324698 324698 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High-definition transcranial electrical stimulation (TES) treatment targeting the anti-correlated activity of the triple brain networks [Salience network (SN), Default mode network (DMN), and Central Executive Network (CEN)] will be administered for four individual treatment sessions, each of 30 minutes duration, by the researcher experienced in administering neuromodulation techniques.

This study will be a double blinded (participant and assessor) pilot randomized placebo-controlled cross-over trial with one-week of washouts in between the four treatments [High definition transcranial infraslow grey noise stimulation (HD-tIGNS), High definition transcranial infraslow black noise stimulation (HD-tIBNS), High definition transcranial infraslow violet noise stimulation (HD-tIVNS), and Acti-sham stimulation]. Each of the four interventions will be administered for a single session of 30 minutes (i.e., each participant will attend only 4 treatment sessions in total; with one of the four treatments administered at each session in a randomised order).

A battery-driven wireless 32 channel transcranial current stimulator (Starstim32 TES®, Neuroelectrics, Spain, http://www.neuroelectrics.com) will be used to deliver stimulation while the participants are comfortably and quietly seated. The Starstim32 is a high definition system with small electrode size that can focally target deeper brain regions. Forty circular Ag/AgCl stimulation electrodes will be placed on a neoprene head cap following the International 10-20 EEG system.

For the active stimulation phases (HD-tIGNS, HD-tIBNS, and HD-tIVNS), the stimulation will be delivered at a current strength of maximum of 2mA for 30min, with 60s ramp up and ramp down at the beginning and the end of each stimulation session, with continuous stimulation in between. The montage of stimulating electrodes for the active stimulation phase will be C1, CP3, CP4, F5, F8, FC1, FC3, FP2, P3, P7, and T7. All the conditions for the three active treatment arms will remain same, except that a different stimulation waveform (HD-tIGNS, HD-tIBNS, and HD-tIVNS) will be used based on the treatment arm.

Adherence of the intervention will be monitored using session attendance checklist.
Intervention code [1] 324412 0
Treatment: Devices
Comparator / control treatment
For sham stimulation phase, to create an identical skin sensation to the active stimulation, the actisham protocol created by the neuroelectrics will be used. The current will be applied for a 60s ramp up and 60s ramp down at the beginning of each stimulation session, without any current for the remainder of the stimulation period. This sham procedure has been previously shown to effectively blind participants to the stimulation condition, as it can induce the same scalp sensations perceived during active stimulation, both in terms of intensity and localization, while preventing currents from reaching the cortex and causing changes in brain excitability. The montage of stimulating electrodes for the sham stimulation phase will be AF8, F8, FP2, P3, P7, and P5.
Control group
Placebo

Outcomes
Primary outcome [1] 332514 0
Cambridge Neuropsychological Test Automated Battery (CANTAB) test battery: Reaction Time (RTI)
Timepoint [1] 332514 0
Baseline and immediately post individual treatment sessions.
Primary outcome [2] 332515 0
CANTAB test battery: Spatial Working Memory (SWM)
Timepoint [2] 332515 0
Baseline and immediately post individual treatment sessions.
Primary outcome [3] 332516 0
CANTAB test battery: Pattern Recognition Memory (PRM)
Timepoint [3] 332516 0
Baseline and immediately post individual treatment sessions.
Secondary outcome [1] 413796 0
Executive function: Stroop colour and word test

[This will be a primary outcome measure, but has been listed here because of space limitations above].
Timepoint [1] 413796 0
Baseline and immediately post individual treatment sessions.
Secondary outcome [2] 413916 0
Executive function: Emotional stroop task

[This will be a primary outcome measure, but has been listed here because of space limitations above].
Timepoint [2] 413916 0
Baseline and immediately post individual treatment sessions.
Secondary outcome [3] 413917 0
Executive function: Trail making tests A and B

[This will be a primary outcome measure, but has been listed here because of space limitations above].
Timepoint [3] 413917 0
Baseline and immediately post individual treatment sessions.
Secondary outcome [4] 413918 0
Resting-state Electroencephalography (EEG) [Current source density and functional and effective connectivity at the targeted triple network (SN, DMN, CEN) brain regions].

[This will be a primary outcome measure, but has been listed here because of space limitations above].
Timepoint [4] 413918 0
Baseline and immediately post individual treatment sessions.
Secondary outcome [5] 413919 0
Safety measures: Any adverse events or side effects (e.g. tingling or burning under stimulation electrodes). Participants will be asked to report the side-effect and rate the intensity on a scale of 0-10, and the relationship of the side-effects to the intervention on a likert scale of 1 to 5 [1 being strongly unrelated, 3 being neutral, and 5 being strongly related].

[This will be a primary outcome measure, but has been listed here because of space limitations above].
Timepoint [5] 413919 0
During each intervention session, and immediately post individual treatment sessions.
Secondary outcome [6] 413921 0
State-Trait Anxiety Inventory (STAI) questionnaire
Timepoint [6] 413921 0
Baseline and immediately post individual treatment sessions.
Secondary outcome [7] 413946 0
CANTAB test battery: Motor Screening Task (MOT)

[This will be a primary outcome measure, but has been listed here because of space limitations above].
Timepoint [7] 413946 0
Baseline and immediately post individual treatment sessions.

Eligibility
Key inclusion criteria
To be included in the study, participants must meet all of the following inclusion criteria:
• Capable of understanding and signing an informed consent form
• Cognitively healthy, as determined by age norms of Mini Mental Status Examination
• Age between 35 to 75 years on the day of the consent and
• Right dominant
Minimum age
35 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who meet any of the following conditions will be excluded:
• History of neurological disease
• History of epileptic seizures
• Unstable medical or psychiatric conditions
• Presence of any pacemaker or defibrillator
• Presence of any implant in head/neck
• Alcohol or substance abuse
• History of any peripheral neuropathy or vascular pathology
• Currently taking any anti-epileptic medications

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The order of the four treatments (HD-tIGNS, HD-tIVNS, HD-tBNS, Sham) will be randomized for each participant.

A research administrator, not involved in the treatment or assessment procedures, will randomise eligible volunteers using an open-access randomization software program, to start with either a) HD-tIGNS, b) HD-tIVNS c) HD-tBNS or d) Sham.

The randomisation schedule will be concealed in a number sealed and opaque envelopes and will be opened at the individual testing session.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
This pilot study is a double-blinded randomized placebo-controlled cross-over trial with one-week of washouts in between the four treatments (HD-tIGNS, HD-tIVNS, HD-tBNS, Sham), and the outcome measures collected immediately pre- and post-interventions.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
SPSS version 22.0 will be used for all statistical analyses. Descriptive statistics will be used to analyse safety measures. Percentage change to baseline will be calculated for the primary and secondary measures. Simple statistical analysis (e.g., Kruskal – Wallis test) will be used to obtain estimates of the intervention effects on primary and secondary outcome measures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/09/2022
Actual
Date of last participant enrolment
Anticipated
31/05/2023
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment outside Australia
Country [1] 25004 0
New Zealand
State/province [1] 25004 0
Otago

Funding & Sponsors
Funding source category [1] 312223 0
Charities/Societies/Foundations
Name [1] 312223 0
Healthcare Otago Charitable Trust
Country [1] 312223 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
362 Leith Street, North Dunedin, Dunedin 9016, New Zealand
Country
New Zealand
Secondary sponsor category [1] 313754 0
None
Name [1] 313754 0
NA
Address [1] 313754 0
NA
Country [1] 313754 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311601 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 311601 0
Ethics committee country [1] 311601 0
New Zealand
Date submitted for ethics approval [1] 311601 0
22/03/2022
Approval date [1] 311601 0
27/06/2022
Ethics approval number [1] 311601 0
2022 FULL 12519

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121674 0
Dr Divya Adhia
Address 121674 0
201 Great King Street, Dunedin hospital, 6th floor, Room 607,
Department of Surgical Sciences, Otago Medical School, University of Otago.
Dunedin
9013
New Zealand
Country 121674 0
New Zealand
Phone 121674 0
+64 211167594
Fax 121674 0
Email 121674 0
[email protected]
Contact person for public queries
Name 121675 0
Divya Adhia
Address 121675 0
201 Great King Street, Dunedin hospital, 6th floor, Room 607,
Department of Surgical Sciences, Otago Medical School, University of Otago.
Dunedin
9013
New Zealand
Country 121675 0
New Zealand
Phone 121675 0
+64 211167594
Fax 121675 0
Email 121675 0
[email protected]
Contact person for scientific queries
Name 121676 0
Divya Adhia
Address 121676 0
201 Great King Street, Dunedin hospital, 6th floor, Room 607,
Department of Surgical Sciences, Otago Medical School, University of Otago.
Dunedin
9013
New Zealand
Country 121676 0
New Zealand
Phone 121676 0
+64 211167594
Fax 121676 0
Email 121676 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.