Home-Based tDCS for Depression in Multiple Sclerosis: A Randomized Sham-Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This project is a double-blind, sham-controlled, parallel-arm, randomized controlled trial. We will recruit n=170 people living with MS, who are experiencing an episode of depression in the context of a major depressive episode (MDE). Using our remotely supervised (RS) tDCS protocol, enrolled participants will complete 30 days of 30-minute tDCS (2.0, DLPFC left anodal) while listening to mindfulness meditation. Over the course of the study, participants will complete assessments of depression and MS symptoms. Participants will be randomized 1:1 active:sham tDCS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age: 18-65 years (inclusive)

• Diagnosis: Confirmed diagnosis of multiple sclerosis (MS), including relapsing-remitting or secondary progressive subtypes

• Stable Medications: Stable use of antidepressant and disease-modifying therapies (DMTs) for at least 30 days prior to enrollment

• Stable Disease Activity: Defined as no clinical relapse, no new radiological disease activity, and no recent steroid treatment for at least 30 days prior to enrollment

• Provider Contact: Confirmed access to a local provider that has primary responsibility for the subjects' clinical care, and who is available for contact in case of increased subject risk due to depressive symptoms

• Technical Ability: Ability to use mobile devices and participate in remote, video-supervised sessions

Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Shayna Pehel
Shayna.Pehel@nyulangone.org
929-455-5104
Time Frame
Start Date: 2025-08-11
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 170
Treatments
Experimental: Active tDCS
Participants will complete 30 x 30 minute daily (M-F) sessions of active tDCS which will be paired with a mindfulness meditation audio track.
Sham_comparator: Sham tDCS
Participants will complete 30 x 30 minute daily (M-F) sessions of sham tDCS which will be paired with a mindfulness meditation audio track.
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health
Collaborators: National Multiple Sclerosis Society

This content was sourced from clinicaltrials.gov

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