Clinical trial NCT06901687: Home-Based Transcranial Direct Current Stimulation (tDCS) for Depression in Multiple Sclerosis (MS)
Official title: Home-Based tDCS for Depression in Multiple Sclerosis: A Randomized Sham-Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Multiple Sclerosis
Depression
Keywords: Multiple Sclerosis
Depression
Neuromodulation
Home-Based
transcranial direct current stimulation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2025-03-30
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Change in Hamilton Depression Rating Scale (HDRS-17)
timeFrame: Baseline, Week 8 (End of Intervention)
measure: Change in Hamilton Depression Rating Scale (HDRS-17)
timeFrame: Baseline, Month 3
Secondary outcomes:
measure: Change in SymptoMScreen Score
timeFrame: Baseline, Week 8 (End of Intervention)
measure: Change in SymptoMScreen Score
timeFrame: Baseline, Month 3
measure: Change in Cognitive Processing Speed (SDMT)
timeFrame: Baseline, Week 8 (End of Intervention)
measure: Change in Cognitive Processing Speed (SDMT)
timeFrame: Baseline, Month 3
measure: Change in Quality of Life in Neurological Disorders (Neuro-QOL) Scale v1.0 - Communication Score
timeFrame: Baseline, Week 8 (End of Intervention)
measure: Change in Quality of Life in Neurological Disorders (Neuro-QOL) Scale v1.0 - Communication Score
timeFrame: Baseline, Month 3
measure: Proportion of Participant who Achieve Clinical Response per HDRS-17 at End of Intervention
timeFrame: Week 8 (End of Intervention)
measure: Proportion of Participant who Achieve Clinical Response per HDRS-17 at Month 3 Follow-Up
timeFrame: Month 3
measure: Proportion of Participant who Achieve Remission per HDRS-17 at End of Intervention
timeFrame: Week 8 (End of Intervention)
measure: Proportion of Participant who Achieve Remission per HDRS-17 at Month 3 Follow-Up
timeFrame: Month 3
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Leigh Charvet, PhD
role: PRINCIPAL_INVESTIGATOR
References: