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

Phase 2

Not yet recruiting

• Conditions: Multiple Sclerosis; Depression

• Registration Number: NCT06901687
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Study Start: 2025-06-01
• Primary Completion: 2028-01-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 170

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, epilepsy, mild cognitive impairment (MCI), dementia), major psychiatric disorders (e.g., bipolar disorder, psychotic disorders), or serious medical conditions (e.g., myocardial infarction, thyroid disease, diabetes with complications, atrial fibrillation)
• Substance Use: Nicotine use (e.g., smoking or vaping) within the past 6 months
• Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the study period, or breastfeeding. If able to become pregnant, participants will be required to use medically accepted birth control methods, including hormonal methods (e.g., pills, patches, implants), barrier methods (e.g., condoms or diaphragm with spermicide), intrauterine device (IUD), or abstinence. Participants will be advised not to become pregnant during the study.
• Seizure History: History of seizures or seizure disorder within the past 5 years
• Implanted Devices or Metal Objects: Presence of metal in the head/neck area (excluding dental fillings) or implanted medical devices (e.g., neurostimulators, pacemakers, defibrillators)
• Skin Conditions: Active skin disorders or skin sensitivity near electrode application sites

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Hamilton Depression Rating Scale (HDRS-17)	Baseline, Month 3	HDRS-17 is a 17-item assessement of depression symptoms. Each item is rated on a Likert scale; the total score is the sum of responses and ranges from 0-52, with higher scores indicating greater levels of depression. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.

Secondary Outcome Measures

Name	Time	Method
Change in SymptoMScreen Score	Baseline, Month 3	12-item measure of overall MS symptom burden. Each item is rated on a scale from 0 (not affected at all) to 6 (total limitation). The total score is the sum of responses and ranges from 0 to 72; higher scores indicate greater overall MS symptom burden.
Change in Cognitive Processing Speed (SDMT)	Baseline, Month 3	The Symbol Digit Modalities Test (SDMT) scores the total number of correct symbol-digit substitutions within 90 seconds, with a higher score indicating better cognitive processing speed. The maximum possible score is 110, the minimum possible score is 0.
Change in Quality of Life in Neurological Disorders (Neuro-QOL) Scale v1.0 - Communication Score	Baseline, Month 3	Neuro-QOL Scale - Communication Subscale comprises 5 items assessing respondents' difficulty in performing everyday tasks requiring communication. Each item is rated on a scale from 1 (cannot perform) to 5 (no difficulty). The total score is the sum of responses and ranges from 5-25; higher scores indicate greater communication abilities function.
Proportion of Participant who Achieve Clinical Response per HDRS-17 at End of Intervention	Week 8 (End of Intervention)	Clinical response is defined as a ≥ 50% reduction in HDRS-17 score from baseline to end of intervention.
Proportion of Participant who Achieve Clinical Response per HDRS-17 at Month 3 Follow-Up	Month 3	Clinical response is defined as a ≥ 50% reduction in HDRS-17 score from baseline to end of intervention.
Proportion of Participant who Achieve Remission per HDRS-17 at End of Intervention	Week 8 (End of Intervention)	Clinical response is defined as a HDRS-17 score ≤ 7 at the end of intervention.
Proportion of Participant who Achieve Remission per HDRS-17 at Month 3 Follow-Up	Month 3	Clinical response is defined as a HDRS-17 score ≤ 7 at the end of intervention.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States