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Recruiting Phase 2 NCT06901687

Home-Based Transcranial Direct Current Stimulation (tDCS) for Depression in Multiple Sclerosis (MS)

Trial Parameters

Condition Multiple Sclerosis
Sponsor NYU Langone Health
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 170
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-08-11
Completion 2028-01-01
Interventions
Active tDCSSham tDCS

Brief 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 Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Neurological or Medical Disorders: History of primary neurological disorder other than MS (e.g., stroke, Parkinson's disease, traumatic brain injury (TBI), intracranial mass, epilep

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