Recruiting
Phase 2

tDCS

Sponsor:

NYU Langone Health

Code:

NCT06901687

Conditions

Multiple Sclerosis

Depression

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Active tDCS

Sham tDCS

Study Details

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.

Conditions

Multiple Sclerosis

Depression

Study ID

NCT06901687

Start date

Aug 11, 2025

Status verified date

Jun, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Active tDCS

tDCS is a noninvasive brain stimulation technique that delivers a low-intensity electrical current (2.0 mA) through sponge electrodes placed on the scalp. For Active tDCS, the device is programmed to ramp up to 2.0 mA (for 30 seconds), provide constant current throughout session (29 minutes), and then ramp down (for 30 seconds) at the end.

Sham tDCS

tDCS is a noninvasive brain stimulation technique that delivers a low-intensity electrical current (2.0 mA) through sponge electrodes placed on the scalp. For Sham tDCS (or placebo) the device is programmed to ramp up to 2.0 mA (for 30 seconds) followed by a ramp down (30 seconds), with no current delivery for 28 minutes, and then ramp up (for 30-s) and down (for 30-s) at the end.

Primary outcome measure

  • Change in Hamilton Depression Rating Scale (HDRS-17) [ Time Frame: Baseline, Week 8 (End of Intervention) ]
  • Change in Hamilton Depression Rating Scale (HDRS-17) [ Time Frame: Baseline, Month 3 ]

Central Contacts and Locations

Central contacts

Shayna Pehel

929-455-5104Shayna.Pehel@nyulangone.org

Elizabeth Quilty

929-455-5564Elizabeth.Quilty@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10017

Contacts

Shayna Pehel

929-455-5104Shayna.Pehel@nyulangone.org

More Information

Sponsor

NYU Langone Health

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • Multiple Sclerosis
  • Depression
  • Neuromodulation
  • Home-Based
  • transcranial direct current stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-06-29.