- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04138953
Cortical Contributions to Motor Sequence Learning
Characterizing Cortical Contributions to Motor Sequence Learning
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael Borich, DPT, PhD
- Phone Number: 404-712-0612
- Email: michael.borich@emory.edu
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University
-
Atlanta, Georgia, United States, 30329
- Wesley Woods
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- No history of movement impairment or neurodegenerative disease
- Right handedness
- No contraindication to transcranial magnetic stimulation (TMS) or magnetic resonance imaging (MRI).
Exclusion Criteria:
- Participants that are outside the age range of 18-85
- Have a history of head trauma or neurodegenerative disorder
- Report contraindications to TMS.
- Participants over age 65 will be asked to complete the Montreal Cognitive Assessment, and participants with a score of 25 or lower (out of the "normal" range) will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TMS over premotor cortex
Noninvasive brain stimulation in the premotor cortex
|
Transcranial magnetic stimulation, also known as repetitive transcranial magnetic stimulation, is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction. It will be used to create a 'virtual lesion,' disrupting neural activity in a specific brain region to identify whether it is causally involved in a specific behavioral process.
Other Names:
|
Experimental: TMS over primary motor cortex
Noninvasive brain stimulation in the motor cortex
|
Transcranial magnetic stimulation, also known as repetitive transcranial magnetic stimulation, is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction. It will be used to create a 'virtual lesion,' disrupting neural activity in a specific brain region to identify whether it is causally involved in a specific behavioral process.
Other Names:
|
Sham Comparator: Sham TMS over premotor cortex
Sham brain stimulation in the premotor cortex
|
Sham Transcranial Magnetic Stimulation (TMS) over premotor cortex
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in skill after training
Time Frame: Day 1 Post-intervention
|
Degree of sequence learning after receiving one of three types of stimulation: premotor cortex stimulation, primary motor cortex stimulation, or sham stimulation.
Sequence-specific motor learning will be indexed by the difference in response time for repeated sequence responses compared to random sequence responses.
|
Day 1 Post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cortical excitability after sequence learning.
Time Frame: Day 1 post-intervention
|
Evaluate the effect of sequence learning on motor cortical excitability.
Cortical excitability will be indexed by peak-to-peak amplitudes of transcranial magnetic stimulation (TMS)-evoked electromyographic responses in the hand contralateral to the motor cortex targeted by TMS quantified before and after training.
|
Day 1 post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Borich, DPT, PhD, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00115009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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