Assessment of tDCS-Induced Neuronal Responses in Multiple Sclerosis (MS) With Advanced MRI
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Healthy Controls 20 Healthy Controls |
Other: Active tDCS
The simultaneous tDCS will be performed at up to 2 mA dose intensity to determine CMRO2 changes from when the tDCS is on when the tDCS is off. The stimulation (left anodal at DLPFC regions) consists of 15-min up to 4 mA tDCS using 5x5 cm electrode sponge with ~30s ramp-up and ramp-down periods.
Other: Sham (placebo) stimulation
MRI-compatible tDCS off (immediately before and after tDCS)
|
| Experimental: MS Patients 40 individuals diagnosed with MS recruited from the MS Center/ Neurology Department at NYULMC |
Other: Active tDCS
The simultaneous tDCS will be performed at up to 2 mA dose intensity to determine CMRO2 changes from when the tDCS is on when the tDCS is off. The stimulation (left anodal at DLPFC regions) consists of 15-min up to 4 mA tDCS using 5x5 cm electrode sponge with ~30s ramp-up and ramp-down periods.
Other: Sham (placebo) stimulation
MRI-compatible tDCS off (immediately before and after tDCS)
|
Outcome Measures
Primary Outcome Measures
- Cerebral metabolic rate of oxygen (CMRO2): [15 Minutes]
The vastly energetic brain has high cerebral O2 consumption, which is critical for neuronal functions and is proportional to neuronal and synaptic activity changes.
Secondary Outcome Measures
- Neuronal Reactivity (NR) [15 Minutes]
NR represents tDCS-induced global neural reactivity measured by CMRO2 levels in cells available to respond to neural stimuli.
- Functional connectivity (FC) [15 Minutes]
Functional networks of DLPFC will be extracted from pre-processed RS-fMRI data prepared within C-PAC toolbox.
- Fractional Amplitude of Low Frequency Fluctuations (fALFF) [15 Minutes]
fALFF [36] is a RS-fMRI measure that quantifies the baseline neural activity by low frequency oscillations at rest.
- Voxel-mirrored homotopic connectivity (VMHC) [15 Minutes]
VMHC characterizes synchrony in patterns of spontaneous activity between symmetric homotopic (geometrically corresponding) cortical regions (e.g., DLPFC) in each hemisphere.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Standardized SDMT Z-scores ≥3 standard deviations below mean
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Able to understand all study instructions and supply written consent
Exclusion Criteria:
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Extreme claustrophobia
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History of mental retardation, pervasive developmental disorder or other neurological condition associated with cognitive impairment
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Primary psychiatric disorder that would influence ability to participate
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History of seizures or seizure disorder
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History of head trauma in the past year (e.g., head injury, brain surgery) or medical device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator)
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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)
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Treatment for a communicable skin disorder currently or over the past 12 months
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History of uncontrolled or labile hypertension.
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Have any irremovable piercings, implantations or metallic-based tattoos
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History of clinically significant abnormalities on electrocardiogram (EKG)
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Pregnant or breastfeeding
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Current substance abuse disorder
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York University School of Medicine | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
Investigators
- Principal Investigator: Leigh Charvet, MD, NYU Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18-00548