NCT03190590

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

March 20, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2018

Completed
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

June 14, 2017

Last Update Submit

April 26, 2024

Conditions

Keywords

transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

  • Motor skill gain from day 1 to day 5

    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.

    5 Days

Study Arms (3)

Transcranial direct current stimulator (tDCS)

ACTIVE COMPARATOR

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

Procedure: tDCS-NeuroConn.

Transcranial magnetic stimulation (TMS)

ACTIVE COMPARATOR

TMS is delivered noninvasively via a hand-held coil applied to the surface of the head, and a magnetic pulse probes cortical circuitry \[this is not repetitive TMS and so does NOT modulate brain excitability.\]

Procedure: TMS - Magstim.

Sham-tDCS

PLACEBO COMPARATOR

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

Procedure: Sham tDCS

Interventions

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

Transcranial direct current stimulator (tDCS)

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

Transcranial magnetic stimulation (TMS)
Sham tDCSPROCEDURE

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

Sham-tDCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Right-handed dominance
  • Ability to give informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Study Officials

  • Heidi Schambra-Griesemer, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2017

First Posted

June 19, 2017

Study Start

March 20, 2018

Primary Completion

July 18, 2018

Study Completion

July 18, 2018

Last Updated

April 29, 2024

Record last verified: 2024-04

Locations