Examining How Motor Rehabilitation Promotes Brain Reorganization Following Stroke, an MRI Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Lynne Gauthier , PhD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01725919
First received: November 6, 2012
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Stroke
Hemiparesis
Behavioral: CI therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Examining Mechanisms of Neuroplasticity Following Motor Rehabilitation in Stroke

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Assessed via dynamic susceptibility contrast MRI, diffusion tensor MRI, MRI-based myelin mapping, T1-weighted MRI


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Assessed via Wolf Motor Function Test, Action Research Arm Test, Motor Activity Log


Estimated Enrollment: 74
Study Start Date: July 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate CI therapy Behavioral: CI therapy
constraint induced movement therapy
Active Comparator: Delayed CI therapy Behavioral: CI therapy
constraint induced movement therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725919

Contacts
Contact: Lynne V Gauthier, Ph.D. 614-293-6287 Gauthier.33@osu.edu

Locations
United States, Ohio
The Ohio State University, 2154 Dodd Hall Recruiting
Columbus, Ohio, United States, 43210
Contact: Lynne V Gauthier, Ph.D.    614-293-6287    Gauthier.33@osu.edu   
Principal Investigator: Lynne V Gauthier, Ph.D.         
Sponsors and Collaborators
Lynne Gauthier , PhD
Investigators
Principal Investigator: Lynne V Gauthier, Ph.D. The Ohio State U.
  More Information

No publications provided

Responsible Party: Lynne Gauthier , PhD, Assistant Professor of Physical Medicine and Rehabilitation, The Ohio State University
ClinicalTrials.gov Identifier: NCT01725919     History of Changes
Other Study ID Numbers: 60034699
Study First Received: November 6, 2012
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Ohio State University:
motor
stroke
hemiparesis
rehabilitation
constraint induced movement therapy
CI therapy

Additional relevant MeSH terms:
Paresis
Stroke
Cerebral Infarction
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 31, 2014