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Interlimb Transfer Post-stroke

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ClinicalTrials.gov Identifier: NCT03194464
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
This study investigates the effects of sub-maximal exercise to task-failure (e.g., fatigue) with the less involved, or so-called non-paretic hand, in people who have experienced a stroke. In previous work the investigators found that non-paretic hand exercise to task-failure increased excitability of the motor cortex in the more involved hemisphere and produced behavioral improvements in the unexercised paretic hand. Importantly, the magnitude of increased brain excitability is greater than what has been observed following brain stimulation with either repetitive transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS) and lasts longer. This approach could be implemented in the clinical setting and could be accessible to a greater number of people than brain stimulation. The investigators' goals in the current study are to: repeat previous findings in a different group of participants and investigate the neural mechanisms that produce brain and behavioral facilitation in order to inform development of this approach for clinical implementation.

Condition or disease Intervention/treatment
Stroke Other: submaximal exercise (grip)

Detailed Description:

The long-term goal is to restore upper extremity (UE) motor function following stroke. The overall objective of this proposal is to improve the investigators' understanding of neural mechanisms contributing to inter-limb and inter-hemispheric transfer following non-paretic limb exercise to task failure. The investigators will use transcranial magnetic stimulation to probe acute adaptations in cortical excitability, intracortical and inter-hemispheric circuits that accompany behavioral facilitation of the paretic hand.

The work proposed in this two year project will enable the investigators to obtain three data elements critical to complete the working hypothesis:

  1. . Changes in intracortical and interhemispheric inhibition in both hemispheres following non-paretic limb exercise to task-failure.
  2. . Behavioral effects using a motor task involving manipulation and dexterity.
  3. . Determine the persistence and consistency of neural and behavioral facilitation.

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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Neural Mechanisms Mediating Interlimb Transfer Following Stroke
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 30, 2018

Group/Cohort Intervention/treatment
Stroke
individuals with upper-extremity impairment following stroke
Other: submaximal exercise (grip)
participants perform repeated gripping with visual feedback to task failure




Primary Outcome Measures :
  1. Short Intracortical Inhibition (SICI) [ Time Frame: baseline, post task-failure (minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total) ]

    SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using TMS. Here the investigators measure SICI at each point to determine how it is modulated in response to task-failure.

    This is a primary outcome for Aim1 (Extended Session, 12 subjects).


  2. Short intracortical inhibition (SICI) [ Time Frame: baseline, post task-failure (minutes to an hour) for each of 8 repeated sessions ]
    This is a primary outcome for Aim2 (Repeated Sessions, 12 Subjects). SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using TMS


Other Outcome Measures:
  1. Box and Blocks test (BBT) [ Time Frame: baseline, post task-failure (requires variable timeline from minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total) ]
    This is a primary outcome for Aim1 (Extended Session, 12 subjects). The investigators measure BBT (scored as number of blocks transferred in 1 minute, using paretic hand) at each time point: baseline, post-task failure, 45min post, 90min post, 135min post, 180min post, 225min post-task failure to determine the change in paretic hand BBT performance following exercise to task-failure.

  2. Box and Blocks test (BBT) [ Time Frame: baseline, post task-failure (minutes to an hour) for each of 8 repeated sessions ]
    This is a primary outcome for Aim2 (Repeated Sessions, 12 Subjects). The investigators measure BBT (scored as number of blocks transferred in 1 minute, using paretic hand) prior to and following task-failure for each of 8 sessions (2 sessions per week x 4 weeks) to determine the change in paretic hand BBT performance following each session of exercise to task-failure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
please see inclusion criteria
Criteria

Inclusion Criteria:

  • individuals at least 6 months post-stroke in the cortical or sub-cortical distribution with residual upper-extremity hemiparesis
  • Non-Veteran Participants are eligible

Exclusion Criteria:

  • multiple strokes
  • strokes in both hemispheres
  • brainstem/medullary/cerebellar stroke
  • seizure disorder
  • metal implants in head or neck
  • pacemaker or other implanted device
  • inability to produce any measurable grip force

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): NCT03194464


Locations
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United States, California
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, California, United States, 32608
United States, Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Carolynn Patten, PhD North Florida/South Georgia Veterans Health System, Gainesville, FL

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03194464     History of Changes
Other Study ID Numbers: N1759-P
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: No
Keywords provided by VA Office of Research and Development:
hemiparesis
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases