tDCS for the Management of Multiple Sclerosis Related Fatigue

Multiple Sclerosis Clinical Trial

Official title:

Transcranial Direct Current Stimulation (tDCS) for the Management of Multiple Sclerosis Related Fatigue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03838770
• Other study ID #: 18-01406
• Status: Completed
• Phase: N/A
• Start date: April 4, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Active tDCS
Active target 2.0mA tDCS (n=60)
• sham tDCS
sham left-anodal dorsolateral prefrontal cortex (DLFPC) montage

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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