Assessment of tDCS-Induced Neuronal Responses in Multiple Sclerosis (MS) With Advanced MRI

Not Applicable

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT03564496
• Lead Sponsor: NYU Langone Health

Brief Summary

The objective of this trial is to measure the changes in neural activities during tDCS session using Magnetic Resonance Imaging (MRI). Participants (N=60) (20 Healthy Controls and 40 participants with neurological disorders, ie. multiple sclerosis) will be recruited to complete self-report measures and a brief cognitive assessment and then undergo an hour long stand-alone MRI scan while simultaneously undergoing tDCS stimulation. Methodology for this study is the administration of 15-minutes of of active tDCS during MRI acquisition compared to time without active tDCS.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-20
• Study Start: 2018-07-09
• Primary Completion: 2021-09-29
• Study Completion: 2021-09-29
• Results First Submitted: 2023-11-20
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-20
• Last Update Submitted: 2023-12-20
• Results First Posted: 2024-01-17
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cerebral Metabolic Rate of Oxygen (CMRO2)	Intermediate Visit (Month 1)	Measured via MRI. CMRO2 is the amount of O2 the brain consumes per unit of time (in μmol O2/100g tissue per minute)
Neuronal Reactivity (NR)	Baseline, Intermediate Visit (Month 1)	NR represents tDCS-induced global neural reactivity measured by CMRO2 levels in cells available to respond to neural stimuli. NR is measured as the percentage change of CMRO2 from no tDCS to real tDCS.

Secondary Outcome Measures

Name	Time	Method
Quality of Life in Neurological Disorders (Neuro-QOL) Score	Final Visit (Month 4)	36-item assessment of quality of life measures in participants with neurological disorders. This questionnaire will be administered to MS patients only. The raw score is the sum of responses; this score is transformed to a standardized T-score with a mean of 50 and SD of 10. A T-score of 60 indicates worse (undesirable) self-reported health.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States