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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Active tDCS
DevicetDCS 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.
Sham tDCS
DevicetDCS 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.
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Active tDCSExperimental treatment 1 intervention
Group B: Sham tDCSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Hamilton Depression Rating Scale (HDRS-17)
HDRS-17 is a 17-item assessement of depression symptoms. Each item is rated on a Likert scale; the total score is the sum of responses and ranges from 0-52, with higher scores indicating greater levels of depression. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.
Time frame
Baseline, Week 8 (End of Intervention)2
Change in Hamilton Depression Rating Scale (HDRS-17)
HDRS-17 is a 17-item assessement of depression symptoms. Each item is rated on a Likert scale; the total score is the sum of responses and ranges from 0-52, with higher scores indicating greater levels of depression. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.
Time frame
Baseline, Month 3Secondary outcomes
1
Change in SymptoMScreen Score
12-item measure of overall MS symptom burden. Each item is rated on a scale from 0 (not affected at all) to 6 (total limitation). The total score is the sum of responses and ranges from 0 to 72; higher scores indicate greater overall MS symptom burden.
Time frame
Baseline, Week 8 (End of Intervention)2
Change in SymptoMScreen Score
12-item measure of overall MS symptom burden. Each item is rated on a scale from 0 (not affected at all) to 6 (total limitation). The total score is the sum of responses and ranges from 0 to 72; higher scores indicate greater overall MS symptom burden.
Time frame
Baseline, Month 33
Change in Cognitive Processing Speed (SDMT)
The Symbol Digit Modalities Test (SDMT) scores the total number of correct symbol-digit substitutions within 90 seconds, with a higher score indicating better cognitive processing speed. The maximum possible score is 110, the minimum possible score is 0.
Time frame
Baseline, Week 8 (End of Intervention)4
Change in Cognitive Processing Speed (SDMT)
The Symbol Digit Modalities Test (SDMT) scores the total number of correct symbol-digit substitutions within 90 seconds, with a higher score indicating better cognitive processing speed. The maximum possible score is 110, the minimum possible score is 0.
Time frame
Baseline, Month 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
National Multiple Sclerosis Society
Collaborator
Source ClinicalTrials.gov