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Brain Stimulation and Rehabilitation for Adults With Chronic, Severe Arm Motor Impairment After Stroke

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ClinicalTrials.gov Identifier: NCT03538795
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
NIH National Rehabilitation Research Resource to Enhance Clinical Trials
Information provided by (Responsible Party):
Gitendra Uswatte, University of Alabama at Birmingham

Brief Summary:
This pilot study will examine a combination therapy for adults with chronic, severe motor impairment of an arm after stroke. The intervention will combine brain stimulation with physical rehabilitation of the arm on the side of the body more-affected by stroke.

Condition or disease Intervention/treatment Phase
Stroke Hemiplegia Hemiparesis Combination Product: iTBS&eCIMT Not Applicable

Detailed Description:
The overarching goal of this program of research is to develop a therapy that produces meaningful and persistent improvements in function of the more-affected arm in stroke survivors with severe, chronic hemiparesis. No treatment with an established evidence base is available now for this large group, who have barely perceptible voluntary movement of the more-affected fingers and wrist. The lab of E. Taub and G. Uswatte has developed an expanded version of Constraint-Induced Movement therapy (CIMT) for this population that has evidence of efficacy for improving use in daily life of the more-affected arm from a case series and small randomized controlled trial (RCT). The original version of CIMT is a form of physical rehabilitation that has evidence of efficacy from multiple RCTs for improving use in daily life of the more-affected arm in adults with mild to moderate hemiparesis after stroke. CIMT has also been shown to produce neuroplastic changes in both grey and white matter structures. Expanded CIMT (eCIMT) combines CIMT with neurodevelopmental techniques (NDT) for managing tone. Studies from by J. Szaflarski and by others suggest that priming CNS tissue for training by electrically stimulating the brain regions that control the target function with excitatory intermittent theta burst stimulation (iTBS) augments the benefits of neurorehabilitation. This pilot study will evaluate the feasibility of combining eCIMT with brain stimulation by iTBS and, on a preliminary basis, will evaluate whether this combination therapy boosts treatment outcomes relative to eCIMT alone.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Case series, with a no-treatment control period before the intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Priming the Brain for Rehabilitation: Brain Stimulation Followed by Constraint-Induced Movement Therapy in Adults With Severe Arm Paresis After Stroke
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: iTBS&eCIMT
Participants will first receive baseline testing followed by a no-treatment control period. Participants will then be tested again, receive the combination therapy, i.e., iTBS&eCIMT, and then receive post-treatment testing.
Combination Product: iTBS&eCIMT
All will receive eCIMT+iTBS on an outpatient basis for 4 hours/day for 15 consecutive weekdays. eCIMT will include training of the more-affected arm following shaping principles, restraint of the less-affected arm, and the Transfer Package in combination with NDT techniques to reduce tone so that shaping of movement can be carried out. The Transfer Package is a set of behavioral techniques designed to transfer therapeutic gains from the treatment setting to everday life. iTBS will be added to prime the areas of the brain that control movement of the more-affected arm so that the responsiveness of that tissue to motor training is enhanced. Treatment sessions will alternate between 10 minute periods of iTBS (which include time for set-up and transition) and 1-hour periods of eCIMT.
Other Names:
  • CI therapy
  • TMS
  • rTMS
  • Constraint-Induced Movement therapy
  • Transcranial Magnetic Stimulation




Primary Outcome Measures :
  1. Motor Activity Log (MAL) [ Time Frame: Change from Day 0 to Day 42 ]
    Structured interview that assesses use of the more-affected arm in daily life


Secondary Outcome Measures :
  1. Wolf Motor Function Test (WMFT) [ Time Frame: Change from Day 0 to Day 42 ]
    Laboratory motor performance test that assesses motor capacity of the more-affected arm

  2. Canadian Occupational Performance Measure (COPM) [ Time Frame: Change from Day 0 to Day 42 ]
    Structured interview that assesses use of the arms in daily life



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stroke
  • > 12 months after stroke onset
  • severe hemiparesis of more-affected arm

Exclusion Criteria:

  • substantial use of the more-affected arm in daily life
  • frailty or insufficient stamina to carry out the requirements of the therapy
  • other neurological or musculoskeletal problems, including pain, affecting the more-affected arm
  • severe cognitive deficits

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): NCT03538795


Contacts
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Contact: Gitendra Uswatte, PhD 205-975-5089 guswatte@uab.edu
Contact: Edward Taub, PhD 205-934-2471 etaub@uab.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Gitendra Uswatte, PhD    205-975-5089    guswatte@uab.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
NIH National Rehabilitation Research Resource to Enhance Clinical Trials
Investigators
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Principal Investigator: Gitendra Uswatte, PhD University of Alabama at Birmingham

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Responsible Party: Gitendra Uswatte, Professor of Psychology and Physical Therapy, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03538795     History of Changes
Other Study ID Numbers: IRB-170530008
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 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: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Gitendra Uswatte, University of Alabama at Birmingham:
stroke
hemiplegia
hemiparesis
arm
upper-extremity
motor impairment
TMS
brain stimulation
neuroplasticity
Additional relevant MeSH terms:
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Stroke
Hemiplegia
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms