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Search / Trial NCT06901687

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

Launched by NYU LANGONE HEALTH · Mar 24, 2025

Trial Information

Current as of April 29, 2025

Not yet recruiting

Keywords

Multiple Sclerosis Depression Neuromodulation Home Based Transcranial Direct Current Stimulation

ClinConnect Summary

This clinical trial is studying the effects of a treatment called transcranial direct current stimulation (tDCS) on people with multiple sclerosis (MS) who are also experiencing depression. The goal is to see if this home-based treatment can help improve mood and reduce symptoms of depression in individuals living with MS. The trial will involve 170 participants, who will receive either active tDCS treatment or a placebo (sham) treatment for 30 days, during which they will also listen to mindfulness meditation.

To be eligible for this study, participants need to be between 18 and 65 years old and have a confirmed diagnosis of MS, either in its relapsing-remitting or secondary progressive form. They should also be stable on their medications for depression and MS for at least 30 days before joining the trial. Participants will take part in remote sessions where they will receive guidance on how to use the tDCS device. Throughout the study, they will complete assessments to monitor their depression and MS symptoms. It’s important to note that certain medical conditions, recent substance use, and other factors may disqualify someone from participating.

Gender

ALL

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

About Nyu Langone Health

NYU Langone Health is a premier academic medical center located in New York City, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, NYU Langone Health integrates cutting-edge scientific inquiry with patient-centered care, striving to develop new therapies and improve health outcomes across a wide range of medical conditions. The institution is dedicated to fostering collaboration among researchers, clinicians, and patients, ensuring rigorous adherence to ethical standards and regulatory guidelines in all clinical research initiatives. By leveraging its extensive resources and expertise, NYU Langone Health aims to contribute significantly to the advancement of medical knowledge and the enhancement of patient care.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Leigh Charvet, PhD

Principal Investigator

NYU Langone Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported