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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 15, 2014
Last verified: October 2014

March 30, 2012
October 15, 2014
September 2011
September 2015   (final data collection date for primary outcome measure)
Determine the effect of Hebbian- type stimulation on both, functional and structural brain reorganization [ Time Frame: 12 visits ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01569607 on ClinicalTrials.gov Archive Site
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Structurally Reorganizing Motor Cortex in Stroke Patients Through Hebbian-type Stimulation
Structurally Reorganizing Motor Cortex in Stroke Patients Through Hebbian-type Stimulation

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Stroke
  • Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
    Training sessions for 5 days in a row
  • Device: Sham stimulation
    Sham stimulation
  • Experimental: Stimulation
    Intervention: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
  • Sham Comparator: Sham
    Intervention: Device: Sham stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2015
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Farrah Rink, MHSc 678-369-3152 frink@emory.edu
Contact: Cathrin Buetefisch, MD, PhD 404-712-1894 cbuetefisch@emory.edu
United States
 
NCT01569607
IRB00052053, R21HD067906-01A1, SRMC21
No
Cathrin Buetefisch, Emory University
Cathrin Buetefisch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Cathrin Buetefisch, MD, PhD Emory University
Emory University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP