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NCT05555056 | Recruiting | Depression

Enhancing the Effectiveness of Cognitive Behavioral Therapy Using Non-invasive Brain Stimulation
Sponsor:

University of Manitoba

Brief Summary:

The purpose of the proposed study is to examine if a repeated treatment of High Definition Transcranial Direct Current Stimulation (HD-tDCS) can increase the functional connectivity between the left ventrolateral prefrontal cortex and posterior cingulate, which may further enhance the effects of cognitive behavioral therapy with mindfulness classes.

Condition or disease

Depression

Anxiety

Stress Disorders, Post-Traumatic

Intervention/treatment

MxN-9 HD-tES Stimulator (Soterix Inc.)

Sham Stimulation

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 30 participants
Masking : Double
Masking Description : Sham stimulation mode will be used in the HD-tES machine. For sham stimulation, the current will be applied for 30 seconds ramp-up followed by 30 seconds ramp-down, and thus no active stimulation will be administered except for the initial and last 1 minutes.
Primary Purpose : Treatment
Official Title : Enhancing the Effectiveness of Cognitive Behavioral Therapy Using Non-invasive Brain Stimulation
Actual Study Start Date : September 1, 2023
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2025
Arm Intervention/treatment

Active Comparator: Active Stimulation

MxN-9 HD-tES Stimulator (Soterix Inc.) will be used to deliver direct current (High-Definition Transcranial Direct Current Stimulation) to the target brain areas via electrodes and conducive gels. A constant current will be applied for 20 minutes with peak current of 2 mA. The 9 electrodes (8 channels + 1 ground) positions and current intensity have been determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the left VLPFC (x=-50, y=+26, z=+8) and the PCC (x=1, y=-61, z=38) with inward field orientation.

Device: MxN-9 HD-tES Stimulator (Soterix Inc.)

Sham Comparator: Inactive Stimulation

The current will be applied for 30 seconds ramp-up followed by 30 seconds ramp-down, and thus no active stimulation will be administered except for the initial and last 1 minutes of 20 minute stimulation duration.

Device: Sham Stimulation
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • all patients who have agreed to participate in virtual mental health treatment at health care sites throughout Manitoba. Eligible participants will be those enrolled in a range of mental health programs, including CBT, DBT, virtual hospital wards, and group-based treatment (e.g., CBTm, Managing Difficult Emotions, etc). The target population will also include providers and decision makers offering virtual mental health programs. Individuals must meet the following criteria to be eligible to participate in the study: 1) must be a patient/client enrolled in a virtual mental health program OR a provider/decision maker offering a virtual mental health program, and 2) located within Manitoba
Exclusion Criteria
  • contraindication for MRI (e.g., metallic implants and claustrophobia)
Enhancing the Effectiveness of Cognitive Behavioral Therapy Using Non-invasive Brain Stimulation

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Enhancing the Effectiveness of Cognitive Behavioral Therapy Using Non-invasive Brain Stimulation

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Locations

Recruiting

Canada, Manitoba

University of Manitoba

Winnipeg, Manitoba, Canada, R3E0J9