Home-based transcranial direct current stimulation for depression in multiple sclerosis
Home-Based tDCS for Depression in Multiple Sclerosis: A Randomized Sham-Controlled Trial
PHASE2 · NYU Langone Health · NCT06901687
We will test whether daily home-based transcranial direct current stimulation (tDCS) plus guided mindfulness can reduce depression in adults with multiple sclerosis who are experiencing a major depressive episode.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | NYU Langone Health (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06901687 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, sham-controlled, parallel-arm Phase 2 trial enrolling 170 people with multiple sclerosis and a current major depressive episode. Participants are randomized 1:1 to active or sham tDCS and complete 30 daily, 30-minute sessions of 2.0 mA left DLPFC anodal stimulation delivered at home with remote video supervision while listening to mindfulness meditation. Depression and MS symptom measures are collected repeatedly over the course of the study to track changes and safety. The protocol requires stable medications and disease activity for at least 30 days prior to enrollment and relies on participants' ability to use mobile devices and maintain contact with a local provider.
Who should consider this trial
Good fit: Adults 18–65 with confirmed relapsing-remitting or secondary progressive MS who are currently experiencing a major depressive episode, are on stable antidepressant and disease-modifying therapies for at least 30 days, have stable disease activity, can use mobile devices for remote supervision, and have a local provider available for contact.
Not a fit: Patients with other primary neurological disorders (e.g., stroke, Parkinson’s disease, significant traumatic brain injury), recent MS relapse or recent steroid treatment, unstable medications, or inability to participate in remote video-supervised sessions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this home-based approach could reduce depressive symptoms and expand access to a non-pharmacologic treatment option for people with MS.
How similar studies have performed: Prior tDCS studies for depression have shown mixed but encouraging results, and small pilot work on home-based tDCS demonstrates feasibility, but large randomized trials specifically in MS remain limited.
Eligibility criteria
Show full inclusion / exclusion 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, 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
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Leigh Charvet, PhD — NYU Langone Health
- Study coordinator: Shayna Pehel
- Email: Shayna.Pehel@nyulangone.org
- Phone: 929-455-5104
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Sclerosis, Depression, Neuromodulation, Home-Based, transcranial direct current stimulation