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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03564496
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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
Multiple Sclerosis Other: Active tDCS Other: Sham (placebo) stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention 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: Single (Participant)
Primary Purpose: Other
Official Title: Assessment of tDCS-Induced Neuronal Responses in Multiple Sclerosis (MS) With Advanced MRI
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Cerebral metabolic rate of oxygen (CMRO2): [ Time Frame: 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 :
  1. Neuronal Reactivity (NR) [ Time Frame: 15 Minutes ]
    NR represents tDCS-induced global neural reactivity measured by CMRO2 levels in cells available to respond to neural stimuli.

  2. Functional connectivity (FC) [ Time Frame: 15 Minutes ]
    Functional networks of DLPFC will be extracted from pre-processed RS-fMRI data prepared within C-PAC toolbox.

  3. Fractional Amplitude of Low Frequency Fluctuations (fALFF) [ Time Frame: 15 Minutes ]
    fALFF [36] is a RS-fMRI measure that quantifies the baseline neural activity by low frequency oscillations at rest.

  4. Voxel-mirrored homotopic connectivity (VMHC) [ Time Frame: 15 Minutes ]
    VMHC characterizes synchrony in patterns of spontaneous activity between symmetric homotopic (geometrically corresponding) cortical regions (e.g., DLPFC) in each hemisphere.



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564496


Contacts
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Contact: Kai Sherman 929 455 5125 Kai.Sherman@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Kai Sherman, MD    929-455-5125    Kai.Sherman@nyumc.org   
Principal Investigator: Leigh Charvet, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Leigh Charvet, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03564496    
Other Study ID Numbers: 18-00548
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data collection will be for pilot data and exploratory analysis.

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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
Keywords provided by NYU Langone Health:
Anodal transcranial stimulation (tDCS)
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases