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

NCT03538795 | Terminated Results FDA Device

• 1 other identifier: IRB-170530008
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Hemiplegia; Hemiparesis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Day 0 to Day 42

Secondary Outcomes (2)

• Wolf Motor Function Test (WMFT)

  Change from Day 0 to Day 42

• Canadian Occupational Performance Measure (COPM)

  Change from Day 0 to Day 42

Study Arms (1)

iTBS&eCIMT

EXPERIMENTAL

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

Interventions

iTBS&eCIMT 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.

Also known as: CI therapy, TMS, repetitive transcranial magnetic stimulation (rTMS), Constraint-Induced Movement therapy, Transcranial Magnetic Stimulation

iTBS&eCIMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• NIH National Rehabilitation Research Resource to Enhance Clinical Trials: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Stroke; Hemiplegia; Paresis

Interventions

Transcranial Magnetic Stimulation; Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Exercise Therapy; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Gitendra Uswatte
• Organization: University of Alabama of Birmingham

guswatte@uab.edu

205-975-5089

Study Officials

• Gitendra Uswatte, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology and Physical Therapy

Model Details: Case series, with a no-treatment control period before the intervention

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 29, 2018
• Study Start: June 11, 2018
• Primary Completion: February 14, 2019
• Study Completion: August 14, 2020
• Last Updated: December 21, 2020
• Results First Posted: December 21, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)