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

Primary Purpose

Stroke, Hemiplegia, Hemiparesis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iTBS&eCIMT
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, hemiplegia, hemiparesis, arm, upper-extremity, motor impairment, transcranial magnetic stimulation (TMS), brain stimulation, neuroplasticity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

iTBS&eCIMT

Arm Description

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.

Outcomes

Primary Outcome Measures

Motor Activity Log (MAL)
Structured interview that assesses use of the more-affected arm in daily life. Scale range is 0 (no use of the more-affected arm) to 5 (use that is as good before stroke). Higher scores are better. Score reported is change from Day 0 to Day 42.

Secondary Outcome Measures

Wolf Motor Function Test (WMFT)
Laboratory motor performance test that assesses motor capacity of the more-affected arm. Scale range is 0 to infinite. Higher scores are better.
Canadian Occupational Performance Measure (COPM)
Structured interview that assesses use of the arms in daily life

Full Information

First Posted
May 15, 2018
Last Updated
November 23, 2020
Sponsor
University of Alabama at Birmingham
Collaborators
NIH National Rehabilitation Research Resource to Enhance Clinical Trials
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1. Study Identification

Unique Protocol Identification Number
NCT03538795
Brief Title
Brain Stimulation and Rehabilitation for Adults With Chronic, Severe Arm Motor Impairment After Stroke
Official Title
Priming the Brain for Rehabilitation: Brain Stimulation Followed by Constraint-Induced Movement Therapy in Adults With Severe Arm Paresis After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Ran out of funds
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
February 14, 2019 (Actual)
Study Completion Date
August 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
NIH National Rehabilitation Research Resource to Enhance Clinical Trials

4. Oversight

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.
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia, Hemiparesis
Keywords
stroke, hemiplegia, hemiparesis, arm, upper-extremity, motor impairment, transcranial magnetic stimulation (TMS), brain stimulation, neuroplasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Case series, with a no-treatment control period before the intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iTBS&eCIMT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
iTBS&eCIMT
Other Intervention Name(s)
CI therapy, TMS, repetitive transcranial magnetic stimulation (rTMS), Constraint-Induced Movement therapy, Transcranial Magnetic Stimulation
Intervention Description
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 everyday 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.
Primary Outcome Measure Information:
Title
Motor Activity Log (MAL)
Description
Structured interview that assesses use of the more-affected arm in daily life. Scale range is 0 (no use of the more-affected arm) to 5 (use that is as good before stroke). Higher scores are better. Score reported is change from Day 0 to Day 42.
Time Frame
Change from Day 0 to Day 42
Secondary Outcome Measure Information:
Title
Wolf Motor Function Test (WMFT)
Description
Laboratory motor performance test that assesses motor capacity of the more-affected arm. Scale range is 0 to infinite. Higher scores are better.
Time Frame
Change from Day 0 to Day 42
Title
Canadian Occupational Performance Measure (COPM)
Description
Structured interview that assesses use of the arms in daily life
Time Frame
Change from Day 0 to Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gitendra Uswatte, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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