Examining How Motor Rehabilitation Promotes Brain Reorganization Following Stroke, an MRI Study
Information source: Ohio State University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stroke; Hemiparesis
Intervention: CI therapy (Behavioral)
Phase: N/A
Status: Recruiting
Sponsored by: Lynne Gauthier , PhD Official(s) and/or principal investigator(s): Lynne V Gauthier, Ph.D., Principal Investigator, Affiliation: The Ohio State U.
Overall contact: Lynne V Gauthier, Ph.D., Phone: 614-293-6287, Email: Gauthier.33@osu.edu
Summary
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.
Clinical Details
Official title: Examining Mechanisms of Neuroplasticity Following Motor Rehabilitation in Stroke
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Brain structure
Secondary outcome: Motor function
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Lynne V Gauthier, Ph.D., Phone: 614-293-6287, Email: Gauthier.33@osu.edu
The Ohio State University, 2154 Dodd Hall, Columbus, Ohio 43210, United States; Recruiting Lynne V Gauthier, Ph.D., Phone: 614-293-6287, Email: Gauthier.33@osu.edu Lynne V Gauthier, Ph.D., Principal Investigator
Additional Information
Starting date: July 2012
Last updated: April 21, 2015
|