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Completed

NCT Number: NCT03564496

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

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS Administration during MRI

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

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

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.

Primary outcomes

  1. Cerebral Metabolic Rate of Oxygen (CMRO2)

    Time frame: Baseline Visit

    Measured via MRI. CMRO2 is the amount of O2 the brain consumes per unit of time (in μmol O2/100g tissue per minute)

  2. Cerebral Metabolic Rate of Oxygen (CMRO2)

    Time frame: 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)

  3. Neuronal Reactivity (NR)

    Time frame: Baseline Visit (pre-tDCS, post-tDCS)

    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. tDCS will be administered in one visit and will last for approximately 15 minutes.

  4. Neuronal Reactivity (NR)

    Time frame: 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 outcomes

  1. Quality of Life in Neurological Disorders (Neuro-QOL) Score

    Time frame: Baseline Visit

    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.

  2. Quality of Life in Neurological Disorders (Neuro-QOL) Score

    Time frame: Intermediate Visit (Month 1)

    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.

  3. Quality of Life in Neurological Disorders (Neuro-QOL) Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 20, 2018
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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