Multiple SclerosisPhase 2NCT06901687
Home-Based Transcranial Direct Current Stimulation (tDCS) for Depression in Multiple Sclerosis (MS)
A Phase 2 study testing Active tDCS in people with Multiple Sclerosis and Depression, run by NYU Langone Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Depression
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2025to 1 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10017
Shayna Pehel, 929-455-5104, Shayna.Pehel@nyulangone.org
About this study
Official title: Home-Based tDCS for Depression in Multiple Sclerosis: A Randomized Sham-Controlled 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.
- Conditions
- Multiple Sclerosis, Depression
- Being tested
- Active tDCS, Sham tDCS
- Keywords
- Multiple Sclerosis, Depression, Neuromodulation, Home-Based, transcranial direct current stimulation
- Medical subject headings
- Multiple Sclerosis, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
tDCS 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 tDCSDevice
tDCS 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.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Participants will complete 30 x 30 minute daily (M-F) sessions of active tDCS which will be paired with a mindfulness meditation audio track. Receives: Device: Active tDCS |
| Sham tDCS | Sham comparator | Participants will complete 30 x 30 minute daily (M-F) sessions of sham tDCS which will be paired with a mindfulness meditation audio track. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 8 (End of Intervention)
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.
Measured: Baseline, Month 3
Secondary outcomes (10)
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.
Measured: Baseline, Week 8 (End of Intervention)
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.
Measured: Baseline, Month 3
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.
Measured: Baseline, Week 8 (End of Intervention)
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.
Measured: Baseline, Month 3
Change in Quality of Life in Neurological Disorders (Neuro-QOL) Scale v1.0 - Communication Score
Neuro-QOL Scale - Communication Subscale comprises 5 items assessing respondents' difficulty in performing everyday tasks requiring communication. Each item is rated on a scale from 1 (cannot perform) to 5 (no difficulty). The total score is the sum of responses and ranges from 5-25; higher scores indicate greater communication abilities function.
Measured: Baseline, Week 8 (End of Intervention)
Change in Quality of Life in Neurological Disorders (Neuro-QOL) Scale v1.0 - Communication Score
Neuro-QOL Scale - Communication Subscale comprises 5 items assessing respondents' difficulty in performing everyday tasks requiring communication. Each item is rated on a scale from 1 (cannot perform) to 5 (no difficulty). The total score is the sum of responses and ranges from 5-25; higher scores indicate greater communication abilities function.
Measured: Baseline, Month 3
Proportion of Participant who Achieve Clinical Response per HDRS-17 at End of Intervention
Clinical response is defined as a ≥ 50% reduction in HDRS-17 score from baseline to end of intervention.
Measured: Week 8 (End of Intervention)
Proportion of Participant who Achieve Clinical Response per HDRS-17 at Month 3 Follow-Up
Clinical response is defined as a ≥ 50% reduction in HDRS-17 score from baseline to end of intervention.
Measured: Month 3
Proportion of Participant who Achieve Remission per HDRS-17 at End of Intervention
Clinical response is defined as a HDRS-17 score ≤ 7 at the end of intervention.
Measured: Week 8 (End of Intervention)
Proportion of Participant who Achieve Remission per HDRS-17 at Month 3 Follow-Up
Clinical response is defined as a HDRS-17 score ≤ 7 at the end of intervention.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start11 Aug 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Sponsor
- Investigators
- Leigh Charvet, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901687
- Sponsor's protocol ID
- 25-00165
- Status last verified
- Jun 2026
- First submitted
- 24 Mar 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: At this time, there are no plans to share Individual Participant Data (IPD) due to considerations related to participant confidentiality, data security, and the study's intended scope. However, summary-level findings will be disseminated through publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based tDCS for Depression in Multiple Sclerosis: A Randomized Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT06901687
- Acronym / sponsor ID
- 25-00165
- Conditions
- Multiple Sclerosis, Depression
- Keywords
- Multiple Sclerosis, Depression, Neuromodulation, Home-Based, transcranial direct current stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Active tDCSParticipants will complete 30 x 30 minute daily (M-F) sessions of active tDCS which will be paired with a mindfulness meditation audio track. |
| Sham tDCS | Sham comparator | Device: Sham tDCSParticipants will complete 30 x 30 minute daily (M-F) sessions of sham tDCS which will be paired with a mindfulness meditation audio track. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCStDCS 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. | Device | Active tDCS |
| Sham tDCStDCS 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. | Device | Sham tDCS |
Primary outcome
Change in Hamilton Depression Rating Scale (HDRS-17)
Time frame: Baseline, Week 8 (End of Intervention)
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.
Change in Hamilton Depression Rating Scale (HDRS-17)
Time frame: Baseline, Month 3
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.
10 secondary outcomes
Change in SymptoMScreen Score
Time frame: Baseline, Week 8 (End of Intervention)
Change in SymptoMScreen Score
Time frame: Baseline, Month 3
Change in Cognitive Processing Speed (SDMT)
Time frame: Baseline, Week 8 (End of Intervention)
Change in Cognitive Processing Speed (SDMT)
Time frame: Baseline, Month 3
Change in Quality of Life in Neurological Disorders (Neuro-QOL) Scale v1.0 - Communication Score
Time frame: Baseline, Week 8 (End of Intervention)
Change in Quality of Life in Neurological Disorders (Neuro-QOL) Scale v1.0 - Communication Score
Time frame: Baseline, Month 3
Proportion of Participant who Achieve Clinical Response per HDRS-17 at End of Intervention
Time frame: Week 8 (End of Intervention)
Proportion of Participant who Achieve Clinical Response per HDRS-17 at Month 3 Follow-Up
Time frame: Month 3
Proportion of Participant who Achieve Remission per HDRS-17 at End of Intervention
Time frame: Week 8 (End of Intervention)
Proportion of Participant who Achieve Remission per HDRS-17 at Month 3 Follow-Up
Time frame: Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No. At this time, there are no plans to share Individual Participant Data (IPD) due to considerations related to participant confidentiality, data security, and the study's intended scope. However, summary-level findings will be disseminated through publications and presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leigh Charvet, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active tDCS in people with Multiple Sclerosis and Depression, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shayna Pehel (929-455-5104, Shayna.Pehel@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Rating Scale (HDRS-17) (time frame: Baseline, Week 8 (End of Intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.