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Trial record 4 of 14 for:    Colleen Hanlon

Gait Mate: Examining Neural Networks Engaged During Lower Extremity Movement in the MRI

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ClinicalTrials.gov Identifier: NCT03604367
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Collaborator:
MUSC Center for Biomedical Research Excellence (COBRE) in Stroke Recovery
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
Less than 50% of stroke survivors progress to independent community ambulation. Even among the stroke survivors who achieve independent ambulation, significant residual deficits persist in balance and gait speed, with 60% of persons post-stroke reporting limitations in mobility related to walking.Consequently maximizing recovery of locomotor function is the focus of neurorehabilitation efforts worldwide. A recently completed clinical trial from members of this investigative team demonstrated that 6 weeks of treadmill training elicits substantial improvements in over ground walking speed and symmetry in persons following stroke. Consistent with the goals of the South Carolina Stroke Rehabilitation Research Center (SCSRRC) and NIH Brain Initiative, the investigators now plan to investigate the effects treadmill-assisted gait training have on cortical control of bipedal movement in chronic stroke patients. Although previous investigators have assessed neural activity during simulated walking using motor imagery, motor imagery does not simulate the typical sensory feedback associated with active movement. To move the field forward, it is necessary to measure active bipedal movement in the MR-environment in healthy volunteers, before moving forward in stroke patients.

Condition or disease Intervention/treatment Phase
Stroke Motor Activity Device: GAITRite assessment Early Phase 1

Detailed Description:

The overarching goal of this Discovery Proposal is to evaluate neural activity during unipedal and bipedal movement in a cohort of healthy individuals (Aim 1).

The rigor and reproducibility will be evaluated by comparing the results of 1) active movement -Bipedal with 2) active movement -unipedal 4 and 3) imagined movement.

Dependent measures include: 1) head motion during the fMRI task, 2) BOLD signal in the ipsilateral and contralateral motor cortex during the fMRI task, 3) force applied during the fMRI task, and 4) participant feedback using a modified version of the Presence Questionnaire (a standard tool to assess ecological validity of virtual environments.

Each Aim has a development and evaluation aspect. Through this 1 year proposal the investigators will determine if the bipedal fMRI protocol (active movement) is able to engage neural networks more robustly (e.g. greater effect size) than bipedal imagery alone in Healthy Volunteers.

Specific Aim #1: Healthy volunteers: The investigators will test the hypothesis that with active bipedal movement there will be 1) no difference in head movement, but 2) greater motor cortex BOLD signal, 3) smoother force exchange between the feet, 4) higher participant satisfaction than unipedal movement or motor imagery alone. This sample size was selected based on a prior publication of imagined movement. The outcome of this aim may result in the first publication in the field to evaluate bipedal movement in an MR-environment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The investigators will enroll healthy volunteers to determine that with active bipedal movement there will be no difference in head movement, but greater motor cortex BOLD signal, smoother force exchange between the feet, higher participant satisfaction than unipedal movement or motor imagery alone.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Gait Mate: Examining Neural Networks Engaged During Lower Extremity Movement in the MRI
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Experimental: GAITRite assessment
Subjects will undergo the GAITRite assessment of functional walking and then complete the Functional MRI Bipedal paradigm followed by questionnaires and assessments regarding the virtual environment.
Device: GAITRite assessment
The fMRI Bipedal Paradigm will allow investigators to study the effects treadmill-assisted gait training have on cortical control of bipedal movement in chronic stroke patients.
Other Name: fMRI Bipedal Paradigm




Primary Outcome Measures :
  1. fMRI protocols will measure neural function activity during active bipedal movement in healthy volunteers [ Time Frame: Duration of the study, approximately 1 year ]
    Determine if the bipedal fMRI protocol (active movement) is able to engage neural networks more robustly (e.g. greater effect size) than bipedal imagery alone in healthy volunteers.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Age 21-65
  • Right hand dominant
  • Able to read and understand questionnaires and informed consent

Exclusion criteria:

  • Self reported history of cardiac disease, COPD or oxygen dependence, neurological and psychiatric disorders, dementia or previous stroke, major head trauma, severe visual impairment, osteoarthritis, orthopedic problems that limit passive range of motion, illegal drug or alcohol dependence, claustrophobia
  • Non-mri compatible metal implants in the body
  • Pregnant females

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): NCT03604367


Contacts
Contact: Colleen A Hanlon, PhD (843) 792-5732 hanlon@musc.edu
Contact: Daniel H Lench, BS (843) 876-5141 lenchd@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Colleen A Hanlon, PhD    843-792-5732    hanlon@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
MUSC Center for Biomedical Research Excellence (COBRE) in Stroke Recovery
Investigators
Principal Investigator: Colleen A Hanlon, PhD Medical University of South Carolina

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03604367     History of Changes
Other Study ID Numbers: 72777
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data from the primary outcome measurement will be shared via manuscripts and after study completion by request to the Principal Investigator.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: The data will be available immediately after first publication of the results. This is estimated to be at the end of 2019.
Access Criteria: Interested parties should contact the Principal Investigator directly

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Medical University of South Carolina:
fMRI
BOLD Signal
Rehabilitation