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Customized Cortical Stimulation Therapy in the Rehabilitation of Stroke Patients

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ClinicalTrials.gov Identifier: NCT02544503
Recruitment Status : Recruiting
First Posted : September 9, 2015
Last Update Posted : October 15, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Cathrin Buetefisch, Emory University

Brief Summary:
The purpose of this study is to identify and establish how the area of the brain that controls motor function (motor cortex) might serve as a new focus for treatment for stroke. The therapeutic intervention aims to identify protocols that improve motor performance after stroke.

Condition or disease Intervention/treatment Phase
Stroke Device: Single-pulse Transcranial Magnetic Stimulation (TMS) Device: Paired-pulse Transcranial Magnetic Stimulation (ppTMS) Device: Low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) Device: Sham Motor Cortex Stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Customized Cortical Stimulation Therapy in the Rehabilitation of Stroke Patients
Study Start Date : July 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Stroke Patients
Subjects will undergo single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
Device: Single-pulse Transcranial Magnetic Stimulation (TMS)
Single-pulse Transcranial Magnetic Stimulation (TMS) is a brief magnetic pulse that is applied through an air-cooled coil to the section of the head that overlays the motor cortex of the brain. Subjects will be comfortably seated in a dental chair surrounded by a frame that carries a coil holder to assist with the application of TMS to the brain. Single-pulse transcranial magnetic stimulation (TMS) will be administered at 1 month visit and 6 month visit.

Device: Paired-pulse Transcranial Magnetic Stimulation (ppTMS)
Paired-pulse Transcranial Magnetic Stimulation (ppTMS) is two brief sequential magnetic pulses that are applied through an air-cooled coil to the section of the head that overlays the motor cortex of the brain.Subjects will be comfortably seated in a dental chair surrounded by a frame that carries a coil holder to assist with the application of TMS to the brain. Paired-pulse transcranial magnetic stimulation (ppTMS) will be administered at 1 month and 6 month visit.

Device: Low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS)
Low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) is a sequence of brief magnetic pulses that are applied through an air-cooled coil to the section of the head that overlays the motor cortex of the brain.Subjects will be comfortably seated in a dental chair surrounded by a frame that carries a coil holder to assist with the application of TMS to the brain. Low-frequency repetitive transcranial magnetic stimulation (rTMS) will be administered at 1 month and 6 month visit.

Device: Sham Motor Cortex Stimulation
Sham motor cortex stimulation will be applied at 1 month and 6 month visit.

Active Comparator: Healthy Controls
Subjects will undergo single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months.
Device: Single-pulse Transcranial Magnetic Stimulation (TMS)
Single-pulse Transcranial Magnetic Stimulation (TMS) is a brief magnetic pulse that is applied through an air-cooled coil to the section of the head that overlays the motor cortex of the brain. Subjects will be comfortably seated in a dental chair surrounded by a frame that carries a coil holder to assist with the application of TMS to the brain. Single-pulse transcranial magnetic stimulation (TMS) will be administered at 1 month visit and 6 month visit.

Device: Paired-pulse Transcranial Magnetic Stimulation (ppTMS)
Paired-pulse Transcranial Magnetic Stimulation (ppTMS) is two brief sequential magnetic pulses that are applied through an air-cooled coil to the section of the head that overlays the motor cortex of the brain.Subjects will be comfortably seated in a dental chair surrounded by a frame that carries a coil holder to assist with the application of TMS to the brain. Paired-pulse transcranial magnetic stimulation (ppTMS) will be administered at 1 month and 6 month visit.

Device: Low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS)
Low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) is a sequence of brief magnetic pulses that are applied through an air-cooled coil to the section of the head that overlays the motor cortex of the brain.Subjects will be comfortably seated in a dental chair surrounded by a frame that carries a coil holder to assist with the application of TMS to the brain. Low-frequency repetitive transcranial magnetic stimulation (rTMS) will be administered at 1 month and 6 month visit.

Device: Sham Motor Cortex Stimulation
Sham motor cortex stimulation will be applied at 1 month and 6 month visit.




Primary Outcome Measures :
  1. Change in motor function assessed by the Wolf Motor Function Test (WMFT) [ Time Frame: Baseline (1 month post stroke), 6 months post stroke ]
    Arm function be evaluated by the Wolf Motor Function Test (WMFT). The test consists of timed and functional tasks and has 17 items. It is composed of 3 parts: Time, functional ability and strength and includes 15 function-based tasks and 2 strength based tasks. Items 1-6 involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. The examiner will test the less affected upper extremity followed by the most affected side. Scores are based on time taken to complete each task. The median time to complete all tasks will be be used to evaluate motor function. Larger values indicate greater upper extremity motor dysfunction.

  2. Change in motor function assessed by the Perdue Pegboard Test [ Time Frame: Baseline (1 month post stroke), 6 months post stroke ]
    The Perdue Pegboard Test is administered by asking the subject to take pegs from a container, one by one, and place them into the holes on the board, as quickly as possible. Subjects are asked to then remove the pegs from the holes, one by one, and replace them back into the container. Only the dominant hand being evaluated will perform the test. The total time taken to complete the task is recorded. Scores are based on the time taken to complete the test activity, and is recorded in seconds. The results are expressed as the number of pegs placed per second. Increased number of pegs placed per second is indicative of greater manual dexterity and increased change scores indicate the contribution of paired associative stimulation to hand dexterity.

  3. Change in motor function assessed by the Jebsen Test [ Time Frame: Baseline (1 month post stroke), 6 months post stroke ]
    The Jebsen Test assesses weighted and non-weighted hand function. Subjects are assessed through writing, turning over 3 by 5 inch cards, picking up small common objects, simulated feeding, stacking checkers, picking up large objects, and picking up large heavy objects.Patients are required to perform all of the subtests with both the right and left hands, with the non-dominant hand tested first.Time to complete each task is recorded. Total score is calculated as the total time to perform each subtest. A shorter time is a better score.


Secondary Outcome Measures :
  1. Change in use of paretic arm assessed by the Motor Activity Log (MAL) [ Time Frame: Baseline (1 month post stroke), 6 months post stroke ]
    In stroke patients, the use of the paretic arm will be measured using the Motor Activity Log (MAL). The MAL is a structured interview to examine how much and how well the subject uses their more-affected arm outside of the laboratory setting.

  2. Change in primary motor cortex (M1) activity, assessed by Functional Magnetic Resonance Imaging (fMRI) [ Time Frame: Baseline (1 month post stroke), 6 months post stroke ]
    Functional Magnetic Resonance Imaging (fMRI) will be used to determine hand movement related activity in the motor cortex of the brain in all subjects.

  3. Change in surface electromyographic (EMG) activity to detect electrical activity in the muscles [ Time Frame: Baseline (1 month post stroke), 6 months post stroke ]
    The subject's EMG activity from the posterior forearm of both arms will be recorded with MRI compatible shielded surface electrodes while completing a motor task.

  4. Change in Interhemispheric inhibition (IHI) measured by transcranial magnetic stimulation (TMS) [ Time Frame: Baseline (1 month post stroke), 6 months post stroke ]
    With the subjects at rest, interhemispheric Inhibition will be evaluated using TMS.

  5. Change in short interval cortical inhibition (SICI) measured by transcranial magnetic stimulation (TMS) [ Time Frame: Baseline (1 month post stroke), 6 months post stroke ]
    SICI will be measured using paired pulse TMS at an interstimulus interval (ISI) of 2 milliseconds (ms).

  6. Change in active interhemispheric inhibition (aIHI) during pointing task [ Time Frame: Baseline (1 month post stroke), 6 months post stroke ]
    Active IHI will be measured during the pre-movement time period of a pointing task during which subjects manipulate a joystick in response to a visual target presented on a computer screen. Real-time feedback about the joystick position is provided by a cursor moving on a computer screen.Subjects will be instructed to move the cursor as quickly as possible to the center of a target square immediately upon its appearance on the screen.

  7. Change in subject's performance in a manual pointing task after contralesional primary motor cortex transcranial magnetic stimulation (TMS) [ Time Frame: Baseline (1 month post stroke), 6 months post stroke ]
    Subjects will complete a pointing task of increasing difficulty using the paretic hand or the non-paretic hand in a counterbalanced randomized order. Effect of TMS is measured during task performance.

  8. Change in motor threshold after transcranial magnetic stimulation (TMS) [ Time Frame: Baseline (1 month post stroke), 6 months post stroke ]
    The resting motor threshold (MT), defined as the minimum stimulus intensity to evoke an motor evoked potential (MEP) of >50 mV in at least five of ten trials, will be determined to the nearest 1% of maximum stimulator. Change in threshold will be expressed as a percentage.

  9. Change in mean motor evoked potential (MEP) amplitudes, assessed by stimulus response curve (SRC) [ Time Frame: Baseline (1 month post stroke), 6 months post stroke ]
    Change in mean motor evoked potential (MEP) amplitudes at each stimulus intensity will be calculated.

  10. Change in short-interval intracortical excitability (SICE) [ Time Frame: Baseline (1 month post stroke), 6 months post stroke ]
    Change in mean motor evoked potential (MEP) amplitudes elicited at different interstimulus intervals (ISIs) and conditioning pulse (CS) intensities will be calculated as a percentage of the mean test MEP amplitude evoked by testing pulse (TS) alone.

  11. Change in rest interhemispheric inhibition (rIHI) [ Time Frame: Baseline (1 month post stroke), 6 months post stroke ]
    Change in mean motor evoked potential (MEP) amplitudes elicited at different interstimulus intervals (ISIs) and conditioning pulse (CS) intensities will be calculated as a percentage of the mean test MEP amplitude evoked by testing pulse (TS) alone.



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The ability to provide informed consent
  • Ages 50 to 80 years old
  • Male or female

Stroke Patients

  • One cerebral ischemic infarction less than 1 month affecting the primary motor output system of the hand at a cortical (M1) level as defined by magnetic resonance imaging (MRI) of the brain
  • Paresis of the hand for more than 3 days after their cerebral infarction
  • Extension of the wrist (medical research council scale for assessment of muscle power score of at least 3 and greater than 10 degrees) at the time of the enrollment into the study

Healthy Subjects

  • Normal MRI of the brain
  • Normal neuropsychological testing
  • Normal neurological examination

Exclusion Criteria:

Stroke Patients

  • Neurological disorders other than stroke
  • Aphasia that prevents following instructions or inability to communicate effectively with the study team
  • Dementia
  • Moderate or severe depression
  • Contraindication to transcranial magnetic stimulation (TMS) and/or MRI
  • Use of central nervous system (CNS) active drugs that block plasticity

Healthy Subjects

  • Neurological Disease
  • Psychiatric Disease
  • Use of CNS active drugs
  • Contraindication to TMS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544503


Contacts
Contact: Cathrin Buetefisch 4047121894 cathrin.buetefisch@emory.edu

Locations
United States, Georgia
Center for Rehabilitation Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Cathrin Buetifisch    404-712-1894    cathrin.m.buetefisch@emory.edu   
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Cathrin Buetefisch, MD, PhD    404-712-5507    cathrin.buetefisch@emory.edu   
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
Emory University
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Cathrin Buetefisch Emory University

Responsible Party: Cathrin Buetefisch, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT02544503     History of Changes
Other Study ID Numbers: IRB00081238
R01NS090677 ( U.S. NIH Grant/Contract )
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases