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

NCT ID: NCT03564496

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-09
• Study Completion Date: 2021-09-29

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Healthy Controls

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

Group Type: ACTIVE_COMPARATOR

tDCS Administration during MRI

Intervention Type: DEVICE

All participants including healthy controls and MS patients will be given approximately 15 minutes of active tDCS during MRI. The simultaneous tDCS will be performed up to 2 mA dose intensity to determine CMRO2 changes from when the tDCS is on to when the tDCS is off. The stimulation consists of 15-min up to 2 mA tDCS using 5x5 cm electrode sponges with \~30s ramp-up and ramp-down periods.

MS Patients

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.

Group Type: EXPERIMENTAL

tDCS Administration during MRI

Intervention Type: DEVICE

All participants including healthy controls and MS patients will be given approximately 15 minutes of active tDCS during MRI. The simultaneous tDCS will be performed up to 2 mA dose intensity to determine CMRO2 changes from when the tDCS is on to when the tDCS is off. The stimulation consists of 15-min up to 2 mA tDCS using 5x5 cm electrode sponges with \~30s ramp-up and ramp-down periods.

Remotely-supervised Daily tDCS Administration

Intervention Type: DEVICE

While the first tDCS session will be performed at clinic under the full supervision, remaining sessions 2-20 (~ 1 month) will be completed at home with remote monitoring by the study technician. Participants in the HC subgroup who opt-in to the additional 15 minutes of imaging +tDCS may complete the first session remotely.

For at-home tDCS administration, participants will be given the specially-designed tDCS device and headset, study laptop computer for secure video monitoring with study technician (must have internet access) and access to the cognitive training program, a detailed reference manual, and a training video. The device will produce up to 2.0 mA stimulation for around 20 minutes, and will not operate without the correct headset placement. The device will also automatically abort the session if optimal conditions are not maintained. It reports and records a completion code for each session.

Healthy Control subgroup

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.

Group Type: ACTIVE_COMPARATOR

tDCS Administration during MRI

Intervention Type: DEVICE

All participants including healthy controls and MS patients will be given approximately 15 minutes of active tDCS during MRI. The simultaneous tDCS will be performed up to 2 mA dose intensity to determine CMRO2 changes from when the tDCS is on to when the tDCS is off. The stimulation consists of 15-min up to 2 mA tDCS using 5x5 cm electrode sponges with \~30s ramp-up and ramp-down periods.

Remotely-supervised Daily tDCS Administration

Intervention Type: DEVICE

While the first tDCS session will be performed at clinic under the full supervision, remaining sessions 2-20 (~ 1 month) will be completed at home with remote monitoring by the study technician. Participants in the HC subgroup who opt-in to the additional 15 minutes of imaging +tDCS may complete the first session remotely.

For at-home tDCS administration, participants will be given the specially-designed tDCS device and headset, study laptop computer for secure video monitoring with study technician (must have internet access) and access to the cognitive training program, a detailed reference manual, and a training video. The device will produce up to 2.0 mA stimulation for around 20 minutes, and will not operate without the correct headset placement. The device will also automatically abort the session if optimal conditions are not maintained. It reports and records a completion code for each session.

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

Intervention Type: DEVICE

Participants in the healthy control subgroup who are willing may have an additional 15 minutes of imaging combined with 10 minutes of simultaneous tDCS of up to 4.0mA added at the end of their baseline scan. In this case, after the initial imaging and tDCS portion is complete, the participant will remain on the scanner for an additional 15 minutes during which brain imaging will continue and will be combined with 10 minutes of simultaneous tDCS up to 4.0mA. This will be a one-time add-on and will not be required at follow-up.

Interventions

tDCS Administration during MRI

All participants including healthy controls and MS patients will be given approximately 15 minutes of active tDCS during MRI. The simultaneous tDCS will be performed up to 2 mA dose intensity to determine CMRO2 changes from when the tDCS is on to when the tDCS is off. The stimulation consists of 15-min up to 2 mA tDCS using 5x5 cm electrode sponges with \~30s ramp-up and ramp-down periods.

Intervention Type: DEVICE

Remotely-supervised Daily tDCS Administration

While the first tDCS session will be performed at clinic under the full supervision, remaining sessions 2-20 (~ 1 month) will be completed at home with remote monitoring by the study technician. Participants in the HC subgroup who opt-in to the additional 15 minutes of imaging +tDCS may complete the first session remotely.

For at-home tDCS administration, participants will be given the specially-designed tDCS device and headset, study laptop computer for secure video monitoring with study technician (must have internet access) and access to the cognitive training program, a detailed reference manual, and a training video. The device will produce up to 2.0 mA stimulation for around 20 minutes, and will not operate without the correct headset placement. The device will also automatically abort the session if optimal conditions are not maintained. It reports and records a completion code for each session.

Intervention Type: DEVICE

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

Participants in the healthy control subgroup who are willing may have an additional 15 minutes of imaging combined with 10 minutes of simultaneous tDCS of up to 4.0mA added at the end of their baseline scan. In this case, after the initial imaging and tDCS portion is complete, the participant will remain on the scanner for an additional 15 minutes during which brain imaging will continue and will be combined with 10 minutes of simultaneous tDCS up to 4.0mA. This will be a one-time add-on and will not be required at follow-up.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leigh Charvet, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-00548

Identifier Type: -

Identifier Source: org_study_id