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| Name | Class |
|---|---|
| National Multiple Sclerosis Society | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active tDCS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 8 (End of Intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shayna Pehel | Contact | 929-455-5104 | Shayna.Pehel@nyulangone.org | |
| Elizabeth Quilty | Contact | 929-455-5564 | Elizabeth.Quilty@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Leigh Charvet, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10017 | United States |
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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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D003863 | Depression |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Sham tDCS | Device | 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. |
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| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Month 3 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |