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

University of Manitoba

Status: Enrolling

Conditions: Stress Disorders, Post-Traumatic; Depression; Anxiety

Treatments: Device: Sham Stimulation; Device: MxN-9 HD-tES Stimulator (Soterix Inc.)

Study type: Interventional

Funder types: Other

Identifiers

NCT05555056

HS25578

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Active Stimulation

Active Comparator group

Description:

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.

Treatment:

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

Inactive Stimulation

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Stimulation