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

NYU Langone Health

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Device: Optional 15 minutes of imaging + simultaneous tDCS up to 4.0mA; Device: tDCS Administration during MRI; Device: Remotely-supervised Daily tDCS Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT03564496

18-00548

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for MS Patients:

• Participants must be 18 years of age or older
• Standardized SDMT Z-score > - 3.0
• Fatigue Severity Scale score > 36
• Definite MS diagnosis as assessed by licensed physician any subtype including Relapsing Remitting (RRMS), Primary Progressive (PPMS) or Secondary Progressive (SPMS)
• Score of ≤ 7.0 on the Expanded Disability Status Scale
• Clinically stable without disease progression in the past 3 months
• Has stable and continuous access to internet service at home compatible with the study laptop (Wi-Fi or Ethernet cable)
• Adequate internet capacity for remote monitoring, as tested by http://www.speedtest.net/
• Adequate home facilities (enough space, access to quiet and distraction free area)
• Able to commit to the four-week period of training sessions with baseline and two follow-up visits

Exclusion Criteria for MS Patients:

• Extreme claustrophobia
• Relapse or steroid use in previous month
• History of mental retardation, pervasive developmental disorder, or other neurological condition associated with cognitive impairment
• Primary psychiatric disorder that would influence ability to participate
• Current uncontrolled seizure disorder
• Current substance abuse disorder
• Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
• Treatment for a communicable skin disorder currently or over the past 12 months
• Have any irremovable piercings, MRI-contraindicated implantations or metallic based-tattoos
• Pregnant or breastfeeding
• Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition Scaled Score < 85
• Beck Depression Inventory - Fast Screen (BDI-FS) score > 9

Inclusion Criteria for Healthy Controls:

• Participants must be 18 years of age or older
• Standardized SDMT Z-score > - 3.0
• Have not been diagnosed with MS or other neurological disorder
• Adequate internet capacity for remote monitoring, as tested by http://www.speedtest.net/ (HC subgroup only)
• Adequate home facilities including enough space, access to quiet and distraction free area (HC subgroup only)
• Able to commit to the four-week period of training sessions with baseline and one follow-up visit (HC subgroup only)

Exclusion Criteria for Healthy Controls:

• Extreme claustrophobia
• History of mental retardation, pervasive developmental disorder or other neurological condition associated with cognitive impairment
• Primary psychiatric disorder that would influence ability to participate
• Current uncontrolled seizure disorder
• Current substance abuse disorder
• Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
• Treatment for a communicable skin disorder currently or over the past 12 months
• Have any irremovable piercings, MRI-contraindicated implantations or metallic based-tattoos
• Pregnant or breastfeeding

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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73 participants in 3 patient groups

Healthy Controls

Active Comparator group

Description:

Healthy Controls will be given approximately 15 minutes of active tDCS during MRI during the initial visit.

Treatment:

Device: tDCS Administration during MRI

MS Patients

Experimental group

Description:

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.

Treatment:

Device: tDCS Administration during MRI

Device: Remotely-supervised Daily tDCS Administration

Healthy Control subgroup

Active Comparator group

Description:

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.

Treatment:

Device: tDCS Administration during MRI

Device: Optional 15 minutes of imaging + simultaneous tDCS up to 4.0mA

Device: Remotely-supervised Daily tDCS Administration