Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 79 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03564496
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	NYU Langone Health
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Leigh Charvet, MD
Principal Investigator Affiliation	NYU Langone Health
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis

Arms & Interventions

Arms

Active Comparator: Healthy Controls

20 Healthy Controls

Experimental: MS Patients

40 individuals diagnosed with MS recruited from the MS Center/ Neurology Department at NYULMC

Interventions

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

New York University School of Medicine, New York, New York

Status

Recruiting

Address

New York University School of Medicine

New York, New York, 10016

Site Contact

Matthew Lustberg

[email protected]

929-455-5090

Clinical Trials in MS

The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Clinical Trial Finder