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

Primary Purpose

Depression, Anxiety, Stress Disorders, Post-Traumatic

Status

Not yet recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

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

Sham Stimulation

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

University of Manitoba

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active Stimulation

Inactive Stimulation

Arm 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.

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.

Outcomes

Primary Outcome Measures

Functional Connectivity

Functional Connectivity between the targeted brain regions measured by resting state fMRI (level of synchronous fMRI signal, standardized)

Secondary Outcome Measures

Full Information

NCT ID

NCT05555056

First Posted

September 20, 2022

Last Updated

August 8, 2023

Sponsor

University of Manitoba

Collaborators

Winnipeg Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05555056

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2023 (Anticipated)

Primary Completion Date

October 1, 2024 (Anticipated)

Study Completion Date

October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Manitoba

Collaborators

Winnipeg Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Anxiety, Stress Disorders, Post-Traumatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Thirty participants among those who are enrolled in the parent clinical trial will be recruited. Participants will receive 5-week CBTm treatment and a battery of psychological assessment as part of the parent clinical trial. Individuals enrolled in the current study will receive daily HD-tDCS during the period of CBTm treatment (5-week). Half of the individuals will receive real stimulation and the other half will receive sham stimulation. Participants will be scanned with MRI before and after the 5-week treatment. EEG data will be collected before (10 minutes), during (20 minutes) and after (20 minutes) each HD-tDCS session .

Masking

ParticipantOutcomes Assessor

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.

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active Stimulation

Arm Type

Active Comparator

Arm Description

Arm Title

Inactive Stimulation

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

Patients will be stimulated with high definition transcranial direct current stimulation (HD-tDCS) for 5 weeks (every weekdays; one session per day). In each session, a constant current at 2mA will be passed on the target brain areas for 20 minutes.

Intervention Type

Device

Intervention Name(s)

Sham Stimulation

Intervention Description

The same stimulation protocol will be used as in Active stimulation except that a sham mode will be selected in the stimulator machine.

Primary Outcome Measure Information:

Title

Functional Connectivity

Description

Functional Connectivity between the targeted brain regions measured by resting state fMRI (level of synchronous fMRI signal, standardized)

Time Frame

Change from Baseline Functional Connectivity after 5 month HD-tDCS/CBTm treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eun Hyung Choi

Phone

204-787-4897

eun.choi@umanitoba.ca

Facility Information:

Facility Name

University of Manitoba

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 0J9

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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