tDCS for the Management of Multiple Sclerosis Related Fatigue
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03838770 |
Recruitment Status :
Completed
First Posted : February 12, 2019
Last Update Posted : December 16, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Device: Active tDCS Device: sham tDCS | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 122 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Transcranial Direct Current Stimulation (tDCS) for the Management of Multiple Sclerosis Related Fatigue |
Actual Study Start Date : | April 4, 2019 |
Actual Primary Completion Date : | June 30, 2021 |
Actual Study Completion Date : | June 30, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Active |
Device: Active tDCS
Active target 2.0mA tDCS (n=60)
Other Name: Soterix Mini-Ct Device |
Placebo Comparator: Sham |
Device: sham tDCS
sham left-anodal dorsolateral prefrontal cortex (DLFPC) montage |
- change from baseline in the self-reported Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue instrument. [ Time Frame: 7 Days post end of Treatment ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Definite MS diagnosis, all subtypes
- Fatigue Severity Scale score of 36 or greater
- Score of 7.5 or less on the Expanded Disability Status Scale (EDSS) (with caregiver proxy required for those with scores of 7.5 or greater)
- Ability to understand the informed consent process and provide consent to participate in the study
Exclusion Criteria:
- Primary neurologic, psychiatric or other medical disorder other than MS
- History of seizures or seizure disorder
- History of head trauma or medical device in head or neck
- Clinically significant abnormality on EKG
- Current symptomatic treatment for fatigue
- Symbol Digit Modalities Test or SDMT score≥3.0 SD from published norms
- WRAT-4 reading level below average (<85) (estimated general intellectual function)
- Beck Depression Inventory-Fast Screen (BDI- FS) score ≥10
- Current chronic headaches or migraines
- Skin disorder/sensitive near stimulation locations

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838770
United States, New York | |
NYU Langone Health | |
New York, New York, United States, 10016 |
Principal Investigator: | Leigh Charvet, MD | New York Langone Medical Center |
Responsible Party: | NYU Langone Health |
ClinicalTrials.gov Identifier: | NCT03838770 |
Other Study ID Numbers: |
18-01406 |
First Posted: | February 12, 2019 Key Record Dates |
Last Update Posted: | December 16, 2021 |
Last Verified: | December 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). |
Supporting Materials: |
Statistical Analysis Plan (SAP) |
Time Frame: | Beginning 9 months and ending 36 months following article publication. |
Access Criteria: | 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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |