Neurophysiological and Functional Mechanisms of Motor Control and Learning


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Verified June 2017 by New York University School of Medicine

Sponsor:

Information provided by (Responsible Party):

New York University School of Medicine

ClinicalTrials.gov Identifier:

NCT03190590

First received: June 14, 2017

Last updated: June 14, 2017

Last verified: June 2017

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.

Transcranial Direct Current Stimulation Device: tDCS-NeuroConn. Device: TMS – Magstim. Device: Sham tDCS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Diagnostic
Official Title: Neurophysiological and Functional Mechanisms of Motor Control and Learning

Primary Outcome Measures:

Estimated Enrollment: 462
Anticipated Study Start Date: December 1, 2017
Estimated Study Completion Date: December 1, 2021
Estimated Primary Completion Date: March 2, 2021 (Final data collection date for primary outcome measure)
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.

Device: tDCS-NeuroConn.

tDCS is delivered noninvasively via electrodes applied to the surface of the head, and a mild electrical current is given during motor training.

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.]

Device: TMS – Magstim.

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.

Device: Sham tDCS

delivered by briefly turning on and off the stimulator at the beginning of training, which mimics the sensation of true stimulation.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03190590

New York University School of Medicine

Principal Investigator: Heidi Schambra New York University School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03190590     History of Changes
Other Study ID Numbers: 17-00328
Study First Received: June 14, 2017
Last Updated: June 14, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by New York University School of Medicine:

transcranial magnetic stimulation

ClinicalTrials.gov processed this record on June 19, 2017