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Clinical Trials/NCT03538795
NCT03538795
Terminated
Not Applicable

Priming the Brain for Rehabilitation: Brain Stimulation Followed by Constraint-Induced Movement Therapy in Adults With Severe Arm Paresis After Stroke

University of Alabama at Birmingham1 site in 1 country3 target enrollmentJune 11, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Alabama at Birmingham
Enrollment
3
Locations
1
Primary Endpoint
Motor Activity Log (MAL)
Status
Terminated
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 11, 2018
End Date
August 14, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gitendra Uswatte

Professor of Psychology and Physical Therapy

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

  • \> 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

Outcomes

Primary Outcomes

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. 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 Outcomes

  • Canadian Occupational Performance Measure (COPM)(Change from Day 0 to Day 42)
  • Wolf Motor Function Test (WMFT)(Change from Day 0 to Day 42)

Study Sites (1)

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