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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555056
• Other study ID #: HS25578
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: May 2023
• Source: University of Manitoba
• Contact: Eun Hyung Choi
• Phone: 204-787-4897
• Email: eun.choi[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Depression
• Stress Disorders, Post-Traumatic

Intervention

Device:
• MxN-9 HD-tES Stimulator (Soterix Inc.)
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.
• Sham Stimulation
The same stimulation protocol will be used as in Active stimulation except that a sham mode will be selected in the stimulator machine.

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Winnipeg Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Connectivity	Functional Connectivity between the targeted brain regions measured by resting state fMRI (level of synchronous fMRI signal, standardized)	Change from Baseline Functional Connectivity after 5 month HD-tDCS/CBTm treatment