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| Name | Class |
|---|---|
| National Multiple Sclerosis Society | OTHER |
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This is a pragmatic clinical trial that aims to determine the effect of tDCS on symptomatic fatigue in Multiple Sclerosis (MS) patients. This is a randomized, blinded, sham-controlled study design to determine the effect of Transcranial Direct Current Stimulation (tDCS) on MS participants to reduce feelings of fatigue.120 participants with MS and clinically-significant fatigue (as defined by a score of >36 on the Fatigue Severity Scale) will be recruited to participate in either an active or sham treatment condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental |
| |
| Sham | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active tDCS | Device | Active target 2.0mA tDCS (n=60) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in the self-reported Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue instrument. | The minimally important difference representing a clinically significant improvement in patient-reported fatigue on the 7-item PROMIS Fatigue Scale is defined as a 3.0 point change in raw score. Clinically-significant response to tDCS treatment by the conservative measurement of >3.0 points on the PROMIS Fatigue Scale. | 7 Days post end of Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leigh Charvet, MD | New York Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40735472 | Derived | Charvet L, Goldberg J, Li X, Best P, Shaw M, Ryerson LZ, Gutman J, Bikson M, Pilloni G, Krupp L. Enhanced cognitive outcomes with telehealth-based tDCS in multiple sclerosis: Results from a sham-controlled RCT. Mult Scler J Exp Transl Clin. 2025 Jul 28;11(3):20552173251356704. doi: 10.1177/20552173251356704. eCollection 2025 Jul-Sep. |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication.
For individual participant data meta-analysis. Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| 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 | sham left-anodal dorsolateral prefrontal cortex (DLFPC) montage |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |