Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Intervention Model
Single Group Assignment
Intervention Model Description
Case series, with a no-treatment control period before the intervention
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Combination Product: 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 everday 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.
    Other names:
    • CI therapy
    • TMS
    • rTMS
    • Constraint-Induced Movement therapy
    • Transcranial Magnetic Stimulation

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Gitendra Uswatte, PhD
205-975-5089
guswatte@uab.edu

More Details

NCT ID
NCT03538795
Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Gitendra Uswatte, PhD
205-975-5089
guswatte@uab.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.