NCT05555056

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Depression
• Anxiety
• Stress Disorders, Post-Traumatic

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-08-01
• Completion: 2026-08-01
• First posted: 2022-09-26
• Last updated: 2024-07-03

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study