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

NCT ID: NCT03538795

Last Updated: 2020-12-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-11
• Study Completion Date: 2020-08-14

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.

Conditions

Stroke; Hemiplegia; Hemiparesis

Keywords

stroke; hemiplegia; hemiparesis; arm; upper-extremity; motor impairment; transcranial magnetic stimulation (TMS); brain stimulation; neuroplasticity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

iTBS&eCIMT

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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 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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

CI therapy; TMS; repetitive transcranial magnetic stimulation (rTMS); Constraint-Induced Movement therapy; Transcranial Magnetic Stimulation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NIH National Rehabilitation Research Resource to Enhance Clinical Trials

UNKNOWN

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Gitendra Uswatte

Professor of Psychology and Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gitendra Uswatte, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB-170530008

Identifier Type: -

Identifier Source: org_study_id