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

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06901687
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Active tDCS — DEVICE
    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 — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Aug 11, 2025
Status verified
Jul 2025
Primary completion
Jan 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10017
Shayna Pehel
[email protected]
929-455-5104

Find similar trials in New York, NY

By condition
DepressionMultiple sclerosis
By specialty
PsychiatryMental healthBehavioral healthNeurologyBrain disordersAutoimmune disease
By research site
NYU Langone Health· New York, NY

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