- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03190590
Neurophysiological and Functional Mechanisms of Motor Control and Learning
June 26, 2023 updated by: NYU Langone Health
Noninvasive stimulation of the central nervous system, including transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), has been increasingly used in the investigation of cortical plasticity.
The purpose of our study is to understand mechanistically-at the neurophysiological and systems levels-how the brain learns new motor skills.
We propose to study the acquisition, consolidation, and retention of motor skill learning in healthy subjects.
At the behavioral level, we will use movement kinematics to quantify and characterize movement, which allow us to infer functional strategies used by the brain to reduce movement errors.
At a neurophysiological level, we will use TMS to document changes in cortical circuitry, which will allow us to infer neuroplastic changes possibly subserving these strategies.
At a systems level, we will enhance motor system excitability using tDCS, which will enable us to infer the contribution of the stimulated area to the motor system's ability to learn new skills.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10016
- New York University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Right-handed dominance
- Ability to give informed consent
Exclusion Criteria:
- active and/or chronic neurological, psychiatric (including depression), or medical conditions
- psychoactive medication use
- active drug/alcohol dependence or abuse history
- homelessness or other social situation that would preclude consistent visits
- history of head injury (including neurosurgery)
- history of seizure
- inability to comprehend or participate in the procedures involved
- metal in the head (besides in mouth), such as implanted electrodes or devices, shrapnel, surgical clips, or fragments from welding/metalwork
- implanted devices (such as cardiac pacemakers, medical pumps, or intracardiac lines) in the thorax
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Transcranial direct current stimulator (tDCS)
tDCS is delivered noninvasively via electrodes applied to the surface of the head, and a mild electrical current is given during motor training.
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tDCS is delivered noninvasively via electrodes applied to the surface of the head, and a mild electrical current is given during motor training.
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Active Comparator: Transcranial magnetic stimulation (TMS)
TMS is delivered noninvasively via a hand-held coil applied to the surface of the head, and a magnetic pulse probes cortical circuitry [this is not repetitive TMS and so does NOT modulate brain excitability.]
|
TMS is delivered noninvasively via a hand-held coil applied to the surface of the head, and a magnetic pulse probes cortical circuitry [this is not repetitive TMS and so does NOT modulate brain excitability
|
Placebo Comparator: Sham-tDCS
delivered by briefly turning on and off the stimulator at the beginning of training, which mimics the sensation of true stimulation.
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delivered by briefly turning on and off the stimulator at the beginning of training, which mimics the sensation of true stimulation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor skill gain from day 1 to day 5
Time Frame: 5 Days
|
defined as an improvement in performance accuracy at fixed movement speeds (see 5.2 for description of task and outcome).
The delta in accuracy between day 1 and day 5 equates to motor skill learning.
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5 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Heidi Schambra-Griesemer, MD, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2018
Primary Completion (Estimated)
March 20, 2024
Study Completion (Estimated)
March 20, 2024
Study Registration Dates
First Submitted
June 14, 2017
First Submitted That Met QC Criteria
June 14, 2017
First Posted (Actual)
June 19, 2017
Study Record Updates
Last Update Posted (Actual)
June 28, 2023
Last Update Submitted That Met QC Criteria
June 26, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 17-00328
Drug and device information, study documents
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.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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