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Cortical Contributions to Motor Sequence Learning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04138953
Recruitment Status : Suspended (Enrollment and study activities are temporarily suspended due to COVID-19.)
First Posted : October 25, 2019
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Borich, Emory University

Brief Summary:
The long-term objective initiated with this study is to determine which brain areas functionally contribute to learning a motor skill. The primary hypothesis of this trial is that premotor cortex (PMC) is necessary to learn a new motor skill. Participants may undergo a MRI scan to acquire a structural image of their brain to target noninvasive stimulation, using transcranial magnetic stimulation (TMS) to one of two brain areas: PMC or primary motor cortex (M1). A third group of individuals will undergo a placebo stimulation protocol. For all three groups, stimulation will be used to create a transient 'virtual lesion' during motor skill training. Temporarily disrupting the normal activity of these brain regions during training will allow us to determine which regions are causally involved in learning a new motor skill. The primary outcome measure will be the change in skill after training in each group.

Condition or disease Intervention/treatment Phase
Brain Injuries Device: Transcranial Magnetic Stimulation (TMS) Other: Sham TMS Not Applicable

Detailed Description:
Recent findings in humans suggest that motor sequences are represented in the premotor cortex once learned. Studies in animal models have also shown that the premotor cortical areas encode sequence-specific information. However, it is currently unknown if premotor cortical areas are involved in the acquisition or consolidation of sequences in humans. In this project, the investigators will evaluate the functional contributions of human premotor cortex to sequence learning. The primary overarching research objective is to determine the brain regions causally involved in motor skill acquisition and consolidation. The main hypothesis is that disrupting premotor cortex activity during motor sequence learning will reduce the acquisition and consolidation of the skill. Transcranial magnetic stimulation (TMS) will be used to temporarily disrupt activity of premotor cortex or primary motor cortex, and skill learning will be assessed in both groups. A sham stimulation group, where participants will feel the coil on their head and hear the click of the TMS pulses but not actually receive stimulation to the brain, will be used as a control. Participants will be randomly assigned to be in the premotor cortex, primary motor cortex, or sham stimulation group. Participants may be asked to undergo a Magnetic Resonance Imaging (MRI) scan at Wesley Woods prior to TMS testing, which will occur at the Emory Rehabilitation Hospital. The MRI scan would be used to help target TMS to the intended brain area. Participants will be recruited using flyers around the local community. Consent forms will be provided with ample time for the participant to read it over and ask any questions that may arise. Participants will be compensated for their time. The proposed work will be the first to evaluate the causal role of premotor cortex in motor sequence learning in humans. Findings from this project are expected to inform the design and application of therapeutic interventions that improve motor functioning and learning in clinical populations.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Characterizing Cortical Contributions to Motor Sequence Learning
Actual Study Start Date : December 5, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: TMS over premotor cortex
Noninvasive brain stimulation in the premotor cortex
Device: Transcranial Magnetic Stimulation (TMS)

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 Name: TMS

Experimental: TMS over primary motor cortex
Noninvasive brain stimulation in the motor cortex
Device: Transcranial Magnetic Stimulation (TMS)

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 Name: TMS

Sham Comparator: Sham TMS over premotor cortex
Sham brain stimulation in the premotor cortex
Other: Sham TMS
Sham Transcranial Magnetic Stimulation (TMS) over premotor cortex




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04138953


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Wesley Woods
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Michael Borich, DPT, PhD Emory University
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Responsible Party: Michael Borich, Assitant professor, Emory University
ClinicalTrials.gov Identifier: NCT04138953    
Other Study ID Numbers: IRB00115009
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Neurophysiology and motor performance outcome measures will be shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: . Data will be available after publication of primary study results (estimated 12 months after study completion - no end date specified)
Access Criteria: Data will be shared through secure file transfer to researchers requesting access to data collected as part of this study

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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.: No
Keywords provided by Michael Borich, Emory University:
Electrophysiology
Magnetic Resonance imaging (MRI)
Neuroanatomy
Neuroscience
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries