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Brain Stimulation + Cognitive Behavioral Therapy for Depression

N/A
Recruiting
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline functional connectivity after 5 month hd-tdcs/cbtm treatment

Summary

This trial will test if a certain brain stimulation treatment can help increase the effectiveness of cognitive behavioral therapy for people with depression.

Who is the study for?
This trial is for individuals in Manitoba enrolled in virtual mental health programs, such as CBT or DBT, or those who provide these services. It's not suitable for people with MRI contraindications like metallic implants or claustrophobia.
What is being tested?
The study tests if brain stimulation using the MxN-9 HD-tES device can boost the effects of cognitive behavioral therapy and mindfulness classes by improving brain connectivity.
What are the potential side effects?
While not explicitly stated, common side effects of non-invasive brain stimulation may include mild headaches, scalp discomfort at the site of stimulation, lightheadedness, and fatigue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline functional connectivity after 5 month hd-tdcs/cbtm treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline functional connectivity after 5 month hd-tdcs/cbtm treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Functional Connectivity

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active StimulationActive Control1 Intervention
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.
Group II: Inactive StimulationPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of ManitobaLead Sponsor
620 Previous Clinical Trials
206,751 Total Patients Enrolled
17 Trials studying Depression
1,251 Patients Enrolled for Depression
Winnipeg FoundationUNKNOWN
1 Previous Clinical Trials
63 Total Patients Enrolled

Media Library

Active Stimulation Clinical Trial Eligibility Overview. Trial Name: NCT05555056 — N/A
Depression Research Study Groups: Active Stimulation, Inactive Stimulation
Depression Clinical Trial 2023: Active Stimulation Highlights & Side Effects. Trial Name: NCT05555056 — N/A
Active Stimulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05555056 — N/A
Depression Patient Testimony for trial: Trial Name: NCT05555056 — N/A
~10 spots leftby Aug 2025
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