Structurally Reorganizing Motor Cortex in Stroke Patients Through Hebbian-type Stimulation
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Purpose
Stroke is a leading cause of morbidity in the U.S. but identification of treatment strategies to improve outcome is limited by the incomplete understanding of the mechanisms of recovery. M1 reorganization plays a major-role in the recovery of motor deficits post-stroke; hence the importance for further development of rehabilitative strategies that utilize this potential for recovery. Non-invasive cortical stimulation can enhance the beneficial effects of motor training on performance and functional plasticity of motor cortex. Among the different approaches used in these studies, Hebbian-type M1 stimulation is particularly intriguing, as it seems to be more effective when compared to random M1 stimulation. There is emerging evidence that motor training or cortical stimulation related improvement of function are associated with increases in the grey matter of targeted brain areas. While there is therefore some evidence supporting structural reorganization in human M1 in response to motor learning and cortical stimulation, the mechanisms underlying these changes and their relationship to functional plasticity are not known. A better understanding of the sequences of events is critical to development of optimal therapeutic interventions to improve recovery following stroke. In Specific Aim 1, we will determine if repeated exposure to training combined with Hebbian-type M1 stimulation enhances functional M1 reorganization in lesioned M1 of stroke patients. In Specific Aim 2, we will determine if repeated exposure to training combined with Hebbian-type M1 stimulation enhances structural cortical reorganization in lesioned M1 of stroke patients and to explore whether these structural changes are related to the training induced functional cortical reorganization. At the completion of this project, it is our expectation that we will have determined the effect of Hebbian- type stimulation on both, functional and structural brain reorganization, thereby obtaining indirect evidence for the neuronal substrate underlying training related improvement and maintenance of motor function in stroke patients. This knowledge would be expected to have a substantial positive impact on treatment for stroke patients that will significantly improve recovery and would move the field of neurorehabilitation forward.
| Condition | Intervention |
|---|---|
|
Stroke |
Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Device: Sham stimulation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Structurally Reorganizing Motor Cortex in Stroke Patients Through Hebbian-type Stimulation |
- Determine the effect of Hebbian- type stimulation on both, functional and structural brain reorganization [ Time Frame: 12 visits ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Stimulation |
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Training sessions for 5 days in a row
|
| Sham Comparator: Sham |
Device: Sham stimulation
Sham stimulation
|
Eligibility| Ages Eligible for Study: | 45 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 45-80
- Single cerebral ischemic infarction > 6 month affecting the primary motor output system of the hand at a cortical (M1) level as defined by MRI of the brain
- At the time of cerebral infarct a motor deficit of hand of MRC of <4- of wrist and finger extension/flexion movement
- Good recovery of hand function as defined by MRC of 4 or 4+ of wrist- and finger extension/flexion movements
- Ability to perform wrist extension movements
- No other neurological disorder
- No intake of CNS active drugs
- Ability to give informed consent
- Ability to meet criteria of inclusion experiment
- No major cognitive impairment
- No contraindication to TMS or MRI
Contacts and Locations| Contact: Farrah Rink, MHSc | 678-369-3152 | frink@emory.edu |
| Contact: Cathrin Buetefisch, MD, PhD | 404-712-1894 | cbuetefisch@emory.edu |
| United States, Georgia | |
| Emory University School of Medicine | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Farrah Rink, MHSc 678-369-3152 frink@emory.edu | |
| Principal Investigator: Cathrin Buetefisch, MD, PhD | |
| Principal Investigator: | Cathrin Buetefisch, MD, PhD | Emory University |
More Information
No publications provided
| Responsible Party: | Cathrin Buetefisch, Dr. Cathrin Buetefisch, MD, PhD, Emory University |
| ClinicalTrials.gov Identifier: | NCT01569607 History of Changes |
| Other Study ID Numbers: | SRMC21, R21HD067906-01A1 |
| Study First Received: | March 30, 2012 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Emory University:
|
Neurophysiology Transcranial Magnetic Stimulation (TMS) Neurology Stroke Physical Medicine and Rehabilitation |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on June 18, 2013