Structurally Reorganizing Motor Cortex in Stroke Patients Through Hebbian-type Stimulation

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Emory University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cathrin Buetefisch, Emory University
ClinicalTrials.gov Identifier:
NCT01569607
First received: March 30, 2012
Last updated: April 14, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 Study Completion Date: December 2014
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:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-85
  • 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
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: NCT01569607

Contacts
Contact: Farrah Rink, MHSc 678-369-3152 frink@emory.edu
Contact: Cathrin Buetefisch, MD, PhD 404-712-1894 cbuetefisch@emory.edu

Locations
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         
Sponsors and Collaborators
Cathrin Buetefisch
Investigators
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: IRB00052053, R21HD067906-01A1, SRMC21
Study First Received: March 30, 2012
Last Updated: April 14, 2014
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 August 28, 2014