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RecruitingPhase 2

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

Home-Based tDCS for Depression in Multiple Sclerosis: A Randomized Sham-Controlled Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests home-based tDCS, which uses a weak electrical current to stimulate the brain, for depression in adults with multiple sclerosis (MS). Participants are randomly assigned to real or sham (inactive) treatment, supervised by video. They complete 30 days of 30-minute sessions while listening to mindfulness meditation.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 65 years old.
  • Have confirmed MS, including relapsing-remitting or secondary progressive types.
  • Be having an episode of major depression.
  • Have stable use of antidepressants and medicines that slow MS for at least 30 days before joining.
  • Have no MS flare-up, new MS changes on scans, or steroid treatment for at least 30 days before joining.
  • Have a local care provider who can be contacted if depression symptoms raise safety concerns.
  • Be able to use mobile devices and join sessions supervised by video.

Who can't join

  • Have a history of another main brain or nerve disorder, such as stroke, Parkinson’s disease, brain injury, epilepsy, or dementia.
  • Have a history of a major mental health disorder, such as bipolar disorder or a disorder with loss of touch with reality.
  • Have a history of a serious medical condition, such as a heart attack, thyroid disease, diabetes with complications, or an irregular heartbeat called atrial fibrillation.
  • Have used nicotine, such as smoking or vaping, in the past 6 months.
  • Are pregnant, planning pregnancy during the study, or breastfeeding. Those who can become pregnant must use an accepted birth control method or not have sex.
  • Have had seizures or a seizure disorder within the past 5 years.
  • Have metal in the head or neck, other than dental fillings, or an implanted medical device such as a pacemaker.
  • Have an active skin problem or sensitive skin near where the treatment pads go.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

NY