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

Not Applicable

Terminated

• Conditions: Hemiplegia; Hemiparesis; Stroke
• Interventions: Combination Product: iTBS&eCIMT

• Registration Number: NCT03538795
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-24
• Study First Posted: 2018-05-29
• Study Start: 2018-06-11
• Primary Completion: 2019-02-14
• Study Completion: 2020-08-14
• Results First Submitted: 2020-09-23
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-23
• Last Update Submitted: 2020-11-23
• Results First Posted: 2020-12-21
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iTBS&eCIMT	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.

Primary Outcome Measures

Name	Time	Method
Motor Activity Log (MAL)	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 Outcome Measures

Name	Time	Method
Canadian Occupational Performance Measure (COPM)	Change from Day 0 to Day 42	Structured interview that assesses use of the arms in daily life
Wolf Motor Function Test (WMFT)	Change from Day 0 to Day 42	Laboratory motor performance test that assesses motor capacity of the more-affected arm. Scale range is 0 to infinite. Higher scores are better.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States