- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01725919
Examining How Motor Rehabilitation Promotes Brain Reorganization Following Stroke, an MRI Study
March 22, 2023 updated by: Yousef Hannawi, Ohio State University
Examining Mechanisms of Neuroplasticity Following Motor Rehabilitation in Stroke
Constraint-induced movement therapy (CI therapy) is a highly efficacious treatment for residual motor disability in chronic stroke.
Its effectiveness is believed to be due, at least in part, to the therapy's ability to aid the brain in "rewiring itself."
For example, CI therapy produces increases in the amount of grey matter (the parts of the brain where neuron cell bodies are most closely clustered) in certain areas of the human brain (Gauthier et al., 2008).
The cellular and molecular mechanisms that are responsible for this increase in grey matter volume are not known, however.
Thus, it is unclear how the therapy helps brains "rewire" themselves.
This study aims to better understand the timecourse and cellular/molecular nature of brain changes during CI therapy.
Because there is currently no way to directly measure cellular/molecular changes in the brain noninvasively, this study will infer what is happening on a microstructural level using new MRI techniques (three dimensional pictures of the brain).
For example, by charting the timecourse of grey matter changes during CI therapy, and cross-comparing this to what is known about the timecourses of different cellular/molecular processes, the investigators can gain a greater understanding of what cellular processes may be responsible for increases in grey matter.
The investigators will gain additional information about which cellular processes are important for rehabilitation-induced improvement by measuring larger-scale changes (e.g., amount of blood flow through different brain areas) that accompany cellular changes.
The investigators are hopeful that by better understanding how CI therapy can change the brain, the effectiveness of rehabilitation can be improved upon.
For example, insight into the mechanisms of rehabilitation-induced brain change may suggest particular drug targets to increase brain plasticity.
This study will help us better understand how the brain repairs itself after injury.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males or females 18 years of age and over
- Experienced a stroke resulting in mild to moderate hemiparesis (some residual motor function, e.g. able to pick up a washcloth placed flat on a table) at least 6 months prior to enrollment. Suggested active range of motion criteria for this level of impairment include: 45° shoulder abduction and flexion, 20° elbow extension, 20° wrist extension, and 10° extension of thumb and fingers.
- Preserved ability to comprehend and participate in basic elements of the therapy
Exclusion Criteria:
- Concurrent participation in other experimental trials for treatment of motor dysfunction
- Having received botulinum toxin injection within the past 3 months
- Previous intensive rehabilitation in the chronic phase post-stroke
- Serious/uncontrolled medical problems (e.g., dementia, severe pain, end-stage or degenerative diseases)
- Kidney disease as evidenced by eGFR<60
- Anemia
- Sickle cell disease
- History of kidney transplant
- Other evidence/history of renal disease
- Pregnancy
- Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, aneurism clip or implant medication pump that are MRI incompatible
- An implanted brain stimulator
- Permanent tattoo (e.g., eye liner) containing metallic coloring
- Claustrophobia precluding MRI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate CI therapy
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constraint induced movement therapy
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Active Comparator: Delayed CI therapy
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constraint induced movement therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain structure
Time Frame: Participants will be followed for 4-6 weeks. Change in brain structure at mid-treatment (after 1 week of CI therapy), post-treatment (after 2 weeks of therapy), and at 2-week follow-up will be measured.
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Assessed via dynamic susceptibility contrast MRI, diffusion tensor MRI, MRI-based myelin mapping, T1-weighted MRI
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Participants will be followed for 4-6 weeks. Change in brain structure at mid-treatment (after 1 week of CI therapy), post-treatment (after 2 weeks of therapy), and at 2-week follow-up will be measured.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor function
Time Frame: Participants will be followed for 4-6 weeks. Change in motor function at mid-treatment (after 1 week of CI therapy), post-treatment (after 2 weeks of therapy), and at 2-week follow-up will be measured.
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Assessed via Wolf Motor Function Test, Action Research Arm Test, Motor Activity Log
|
Participants will be followed for 4-6 weeks. Change in motor function at mid-treatment (after 1 week of CI therapy), post-treatment (after 2 weeks of therapy), and at 2-week follow-up will be measured.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yousef Hannawi, MD, Ohio State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rafiei MH, Kelly KM, Borstad AL, Adeli H, Gauthier LV. Predicting Improved Daily Use of the More Affected Arm Poststroke Following Constraint-Induced Movement Therapy. Phys Ther. 2019 Dec 16;99(12):1667-1678. doi: 10.1093/ptj/pzz121.
- Kelly KM, Borstad AL, Kline D, Gauthier LV. Improved quality of life following constraint-induced movement therapy is associated with gains in arm use, but not motor improvement. Top Stroke Rehabil. 2018 Oct;25(7):467-474. doi: 10.1080/10749357.2018.1481605. Epub 2018 Sep 22.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
June 30, 2017
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
November 6, 2012
First Submitted That Met QC Criteria
November 8, 2012
First Posted (Estimate)
November 14, 2012
Study Record Updates
Last Update Posted (Actual)
March 23, 2023
Last Update Submitted That Met QC Criteria
March 22, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60034699
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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