Home-Based tDCS for Depression in Multiple Sclerosis: A Randomized Sham-Controlled Trial
NYU Langone Health
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
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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,…
Interventions
- DeviceActive 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.
- DeviceSham 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.
Location
- NYU Langone HealthNew York, New York