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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Device: tDCS Administration during MRI; Device: Remotely-supervised Daily tDCS Administration; Device: Optional 15 minutes of imaging + simultaneous tDCS up to 4.0mA

• 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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Controls	tDCS Administration during MRI	Healthy Controls will be given approximately 15 minutes of active tDCS during MRI during the initial visit.
MS Patients	tDCS Administration during MRI	MS patients will be given approximately 15 minutes of active tDCS during MRI during the initial visit. After the first MRI visit, MS patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC. Around 3 months after the 20-session treatment, MS patients only will be asked to come to the clinic for neuropsychological assessments.
Healthy Control subgroup	Remotely-supervised Daily tDCS Administration	The Healthy Control subgroup will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Participants in the healthy control subgroup will be given the option to have an additional 15 minutes of brain imaging, which will include 10 minutes of simultaneous tDCS at up to 4.0mA, added to the end of their baseline scan. After the first MRI visit, HC subgroup patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC.
Healthy Control subgroup	tDCS Administration during MRI	The Healthy Control subgroup will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Participants in the healthy control subgroup will be given the option to have an additional 15 minutes of brain imaging, which will include 10 minutes of simultaneous tDCS at up to 4.0mA, added to the end of their baseline scan. After the first MRI visit, HC subgroup patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC.
MS Patients	Remotely-supervised Daily tDCS Administration	MS patients will be given approximately 15 minutes of active tDCS during MRI during the initial visit. After the first MRI visit, MS patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC. Around 3 months after the 20-session treatment, MS patients only will be asked to come to the clinic for neuropsychological assessments.
Healthy Control subgroup	Optional 15 minutes of imaging + simultaneous tDCS up to 4.0mA	The Healthy Control subgroup will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Participants in the healthy control subgroup will be given the option to have an additional 15 minutes of brain imaging, which will include 10 minutes of simultaneous tDCS at up to 4.0mA, added to the end of their baseline scan. After the first MRI visit, HC subgroup patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC.

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