Home-Based Transcranial Direct Current Stimulation (tDCS) for Depression in Multiple Sclerosis (MS)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNYU Langone Health
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Active tDCS
- Sham tDCS
Treatment groups
170 Participants
are divided into 2 treatment groupsSponsors and collaborators
NYU Langone Health
Lead sponsor
National Multiple Sclerosis Society
Collaborator
Source ClinicalTrials.gov