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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03564496
• Other study ID #: 18-00548
• Status: Completed
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: September 29, 2021

Study information

• Verified date: December 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: September 29, 2021
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral Metabolic Rate of Oxygen (CMRO2)	Measured via MRI. CMRO2 is the amount of O2 the brain consumes per unit of time (in µmol O2/100g tissue per minute)	Baseline Visit
Primary	Cerebral Metabolic Rate of Oxygen (CMRO2)	Measured via MRI. CMRO2 is the amount of O2 the brain consumes per unit of time (in µmol O2/100g tissue per minute)	Intermediate Visit (Month 1)
Primary	Neuronal Reactivity (NR)	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.	Baseline Visit (pre-tDCS, post-tDCS)
Primary	Neuronal Reactivity (NR)	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.	Baseline, Intermediate Visit (Month 1)
Secondary	Quality of Life in Neurological Disorders (Neuro-QOL) Score	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.	Baseline Visit
Secondary	Quality of Life in Neurological Disorders (Neuro-QOL) Score	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.	Intermediate Visit (Month 1)
Secondary	Quality of Life in Neurological Disorders (Neuro-QOL) Score	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.	Final Visit (Month 4)