Back to resultsAssessment of tDCS-Induced Neuronal Responses in Multiple Sclerosis (MS) With Advanced MRI
Primary Purpose
Multiple Sclerosis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active tDCS
Sham (placebo) stimulation
Sponsored by
About this trial
This is an interventional other trial for Multiple Sclerosis focused on measuring Anodal transcranial stimulation (tDCS)
Eligibility Criteria
Inclusion Criteria:
- Standardized SDMT Z-scores ≥3 standard deviations below mean
- Able to understand all study instructions and supply written consent
Exclusion Criteria:
- 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
- History of seizures or seizure disorder
- 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)
- 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
- History of uncontrolled or labile hypertension.
- Have any irremovable piercings, implantations or metallic-based tattoos
- History of clinically significant abnormalities on electrocardiogram (EKG)
- Pregnant or breastfeeding
- Current substance abuse disorder
Sites / Locations
- New York University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Healthy Controls
MS Patients
Arm Description
20 Healthy Controls
40 individuals diagnosed with MS recruited from the MS Center/ Neurology Department at NYULMC
Outcomes
Primary Outcome Measures
Cerebral metabolic rate of oxygen (CMRO2):
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)
NR represents tDCS-induced global neural reactivity measured by CMRO2 levels in cells available to respond to neural stimuli.
Functional connectivity (FC)
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)
fALFF [36] is a RS-fMRI measure that quantifies the baseline neural activity by low frequency oscillations at rest.
Voxel-mirrored homotopic connectivity (VMHC)
VMHC characterizes synchrony in patterns of spontaneous activity between symmetric homotopic (geometrically corresponding) cortical regions (e.g., DLPFC) in each hemisphere.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03564496
Brief Title
Assessment of tDCS-Induced Neuronal Responses in Multiple Sclerosis (MS) With Advanced MRI
Official Title
Assessment of tDCS-Induced Neuronal Responses in Multiple Sclerosis (MS) With Advanced MRI
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2018 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Anodal transcranial stimulation (tDCS)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
Participant
Allocation
Non-Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Controls
Arm Type
Active Comparator
Arm Description
20 Healthy Controls
Arm Title
MS Patients
Arm Type
Experimental
Arm Description
40 individuals diagnosed with MS recruited from the MS Center/ Neurology Department at NYULMC
Intervention Type
Other
Intervention Name(s)
Active tDCS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham (placebo) stimulation
Intervention Description
MRI-compatible tDCS off (immediately before and after tDCS)
Primary Outcome Measure Information:
Title
Cerebral metabolic rate of oxygen (CMRO2):
Description
The vastly energetic brain has high cerebral O2 consumption, which is critical for neuronal functions and is proportional to neuronal and synaptic activity changes.
Time Frame
15 Minutes
Secondary Outcome Measure Information:
Title
Neuronal Reactivity (NR)
Description
NR represents tDCS-induced global neural reactivity measured by CMRO2 levels in cells available to respond to neural stimuli.
Time Frame
15 Minutes
Title
Functional connectivity (FC)
Description
Functional networks of DLPFC will be extracted from pre-processed RS-fMRI data prepared within C-PAC toolbox.
Time Frame
15 Minutes
Title
Fractional Amplitude of Low Frequency Fluctuations (fALFF)
Description
fALFF [36] is a RS-fMRI measure that quantifies the baseline neural activity by low frequency oscillations at rest.
Time Frame
15 Minutes
Title
Voxel-mirrored homotopic connectivity (VMHC)
Description
VMHC characterizes synchrony in patterns of spontaneous activity between symmetric homotopic (geometrically corresponding) cortical regions (e.g., DLPFC) in each hemisphere.
Time Frame
15 Minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Standardized SDMT Z-scores ≥3 standard deviations below mean
Able to understand all study instructions and supply written consent
Exclusion Criteria:
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
History of seizures or seizure disorder
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)
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
History of uncontrolled or labile hypertension.
Have any irremovable piercings, implantations or metallic-based tattoos
History of clinically significant abnormalities on electrocardiogram (EKG)
Pregnant or breastfeeding
Current substance abuse disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Lustberg
Phone
929 455 5090
Email
matthew.lustberg@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh Charvet, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Lustberg
Phone
929-455-5090
Email
matthew.lustberg@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Leigh Charvet, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data collection will be for pilot data and exploratory analysis.
Learn more about this trial
Assessment of tDCS-Induced Neuronal Responses in Multiple Sclerosis (MS) With Advanced MRI
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