Cortical Contributions to Motor Sequence Learning

NCT04138953 | Completed Results FDA Device

• 1 other identifier: IRB00115009
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Brain Injuries

Keywords

Electrophysiology; Magnetic Resonance imaging (MRI); Neuroanatomy; Neuroscience

Outcome Measures

Primary Outcomes (1)

• Serial Reaction Time Task (SRTT) Performance

  The SRTT involves pressing a key that corresponds to a target square presented on a monitor. Sequenced skill (SS) is calculated by subtracting the response time of sequenced key presses from random key presses within and across a test block. An increase in SS value indicates an increase in sequenced skill and is a preferable result.

  Pre-test (baseline), Post-test (training usually lasts for 3 hours), Retention Test (30 mins following training)

Secondary Outcomes (1)

• Cortical Excitability Measured by Motor Evoked Potentials (MEPs)

  Pre-test (baseline), Post-test (training usually lasts for 3 hours)

Study Arms (3)

TMS over premotor cortex (PMC)

EXPERIMENTAL

Noninvasive brain stimulation in the premotor cortex

Device: Transcranial Magnetic Stimulation (TMS)

TMS over primary motor cortex (M1)

EXPERIMENTAL

Noninvasive brain stimulation in the motor cortex

Device: Transcranial Magnetic Stimulation (TMS)

Sham TMS

SHAM COMPARATOR

Sham brain stimulation

Other: Sham TMS

Interventions

Transcranial Magnetic Stimulation (TMS) DEVICE

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.

Also known as: TMS

TMS over premotor cortex (PMC); TMS over primary motor cortex (M1)

Sham TMS OTHER

Sham Transcranial Magnetic Stimulation (TMS)

Sham TMS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No history of movement impairment or neurodegenerative disease
• Right handedness
• No contraindication to transcranial magnetic stimulation (TMS) or magnetic resonance imaging (MRI).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

Location

Wesley Woods

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Michael Borich, DPT, PhD
• Organization: Emory University

michael.borich@emory.edu

404-712-0612

Study Officials

• Michael Borich, DPT, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant professor

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: December 5, 2019
• Primary Completion: August 4, 2023
• Study Completion: August 4, 2023
• Last Updated: August 28, 2024
• Results First Posted: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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

Locations

US (2)