Structurally Reorganizing Motor Cortex in Stroke Patients Through Hebbian-type Stimulation
3 other identifiers
interventional
48
1 country
1
Brief Summary
Stroke is a leading cause of morbidity in the United States but identification of treatment strategies to improve outcome is limited by the incomplete understanding of the mechanisms of recovery. Motor cortex (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. In Specific Aim 1, investigators 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, investigators 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. The overall goal of this project is to determine 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 may have a substantial positive impact on treatment for stroke patients that may significantly improve recovery and could move the field of neuro-rehabilitation forward.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Mar 2012
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 8, 2012
CompletedFirst Submitted
Initial submission to the registry
March 30, 2012
CompletedFirst Posted
Study publicly available on registry
April 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 26, 2016
CompletedResults Posted
Study results publicly available
January 16, 2018
CompletedJanuary 16, 2018
December 1, 2017
4.5 years
March 30, 2012
October 31, 2017
December 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Motor Cortex (M1) Excitability Derived From Stimulus Response Curve
Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), one week after the treatment (post-training 1), and 4 weeks after treatment (post-training 2).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity. Its amplitude is measured from peak to peak and expressed in millivolts (mV). Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC). Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.
Baseline, Post-Training 1 (1 Week), Post-Training 2 (4 Weeks)
Secondary Outcomes (8)
Mean Time to Completion for Jebsen Hand Function Test (JTT)
Baseline, Post-Training (1 Week), Post-Training (4 Weeks)
Mean Peak Acceleration of Wrist Extension Movements
Baseline, Post-Training (1 Week), Post-Training (4 Weeks)
Mean Reaction Time of Wrist Extension Movements
Baseline, Post-Training (1 Week), Post-Training (4 Weeks)
Mean Motor Activity Log (MAL) Score: Amount Subtest
Baseline, Post-Training (1 Week), Post-Training (4 Weeks)
Mean Motor Activity Log (MAL): How Well Subtest
Baseline, Post-Training (1 Week), Post-Training (4 Weeks)
- +3 more secondary outcomes
Study Arms (2)
Hebbian-type Stimulation
EXPERIMENTALParticipants will be randomized to receive motor training with Hebbian-type stimulation.
Sham Stimulation
SHAM COMPARATORParticipants will be randomized to receive sham stimulation.
Interventions
Training sessions for 5 days in a row
Eligibility Criteria
You may qualify if:
- 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
- No major cognitive impairment
- No contraindication to TMS or MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Related Publications (1)
Revill KP, Haut MW, Belagaje SR, Nahab F, Drake D, Buetefisch CM. Hebbian-Type Primary Motor Cortex Stimulation: A Potential Treatment of Impaired Hand Function in Chronic Stroke Patients. Neurorehabil Neural Repair. 2020 Feb;34(2):159-171. doi: 10.1177/1545968319899911. Epub 2020 Jan 24.
PMID: 31976804DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Cathrin Buetefisch
- Organization
- Emory University
Study Officials
- PRINCIPAL INVESTIGATOR
Cathrin Buetefisch, MD, PhD
Emory University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr. Cathrin Buetefisch, MD, PhD
Study Record Dates
First Submitted
March 30, 2012
First Posted
April 3, 2012
Study Start
March 8, 2012
Primary Completion
August 26, 2016
Study Completion
August 26, 2016
Last Updated
January 16, 2018
Results First Posted
January 16, 2018
Record last verified: 2017-12