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Multifocal Brain Magnetic Stimulation in Chronic Ischemic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02817087
Recruitment Status : Completed
First Posted : June 29, 2016
Results First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Collaborators:
The Methodist Hospital Research Institute
Seraya Medical Systems, LLC
Information provided by (Responsible Party):
David Chiu, MD, The Methodist Hospital Research Institute

Brief Summary:
Transcranial magnetic stimulation for post-stroke upper-body motor deficits.

Condition or disease Intervention/treatment Phase
Stroke Device: repetitive Transcranial Magnetic Stimulation -On Device: repetitive Transcranial Magnetic Stimulation -Off Not Applicable

Detailed Description:

This study uses transcranial magnetic stimulation (magnetic pulses delivered through a specially designed cap worn on the head aimed at specific motor areas of the brain (brain areas responsible for the body's physical movements) to test whether upper-body motor function can be improved.

This is a double-blind study where half of participants will receive active transcranial stimulation and the other half of the participants will receive no transcranial magnetic stimulation; all participants will wear the cap. Participants and some members of the research team will not know who received active magnetic brain stimulation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Active repetitive transcranial magnetic stimulation administered through cap worn by patient under healthcare provider.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double-blind, only the care provider is aware of active treatment assignment.
Primary Purpose: Treatment
Official Title: An Innovative Approach to Restoration of Function in Chronic Ischemic Stroke Using a New Wearable Multifocal Brain Stimulator
Actual Study Start Date : May 27, 2016
Actual Primary Completion Date : March 13, 2019
Actual Study Completion Date : March 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arm Intervention/treatment
Active Comparator: repetitive Transcranial Magnetic Stimulation -On
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.
Device: repetitive Transcranial Magnetic Stimulation -On
Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain
Other Names:
  • transcranial magnetic stimulation (TMS)
  • Transcranial Rotating Permanent Magnet Stimulation (TRPMS)
  • repetitive Transcranial Magnetic Stimulation (rTMS)

Sham Comparator: repetitive Transcranial Magnetic Stimulation -Off
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.
Device: repetitive Transcranial Magnetic Stimulation -Off
Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment.
Other Names:
  • sham treatment
  • Control Group




Primary Outcome Measures :
  1. Changes in Brain Activation [ Time Frame: One business day before treatment begins, one business day after treatment ends, up to 5 weeks ]
    Change in number of active voxels in the cortical areas surrounding the lesion on functional MRI


Secondary Outcome Measures :
  1. Fugl-Meyer Motor Arm Score [ Time Frame: One business day before treatment begins, one business day after treatment ends up to 5 weeks ]
    Change in arm motor function Total score range is 0-66 with the higher number representing a better outcome

  2. ARAT (Action Research Arm Test) [ Time Frame: One business day before treatment begins, one business day after treatment ends up to 5 weeks ]
    Change in arm and hand motor function Total score range is 0-57 with the higher number representing a better outcome

  3. Hand Dynamometer [ Time Frame: One business day before treatment begins, one business day after treatment ends up to 5 weeks ]
    Change in grip strength The higher the number represents better outcome

  4. Pinch Dynamometer Score [ Time Frame: One business day before treatment begins, one business day after treatment ends up to 5 weeks ]
    Change in pinch strength. The higher the number, the better the outcome.

  5. TUG (Timed Up and Go Test) [ Time Frame: One business day before treatment begins, one business day after treatment ends up to 5 weeks ]
    Change in gait velocity on Timed Up and Go Test. The lower the time recorded, the better the outcome.

  6. National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: One business day before treatment begins, one business day after treatment ends up to 5 weeks ]
    Change in National Institutes of Health Stroke Scale (NIHSS) Total score range is 0-42 with the lower number representing a better outcome



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18-80 years;
  • Clinical diagnosis of chronic ischemic stroke recovering for more than 3 months with unilateral motor deficits of arm and leg, or arm alone; --

Exclusion Criteria:

  • History of seizure;
  • Epileptogenic activity (indicative of increased risk of seizures) on EEG;
  • Any active unstable medical condition;
  • Pregnancy;
  • Schizophrenia, bipolar disorder, alcoholism, or substance abuse;
  • Medications which in the investigator's clinical judgment significantly lower the seizure threshold;
  • Presence of metal or electronic implants in the head (or any in the body that preclude MRI) , including pacemakers, defibrillators, aneurysm clips, neuro-stimulators, cochlear implants, metal in the eyes, etc.;
  • Any changes in medications prescribed for the treatment of stroke impairment within six weeks prior to inclusion in the study or at any time during the study.
  • Botulinum toxin use within two months prior to the screening visit or any planned use of botulinum toxin during the study
  • Changes in NIHSS and motor assessment scores between Visit 1 and Visit 2 indicating that the patient's impairment is not stable. The following cutoffs, based on research establishing Clinically Important Differences, will be used for this determination:
  • National Institutes of Health Stroke Scale: A change in total score of more than 2 points in either direction, or a change in the motor extremity score of more than 1 point in either direction.
  • Fugl-Meyer Assessment of Sensorimotor Impairment: A change of more than 5 points in either direction on the upper-extremity motor score for the affected arm.
  • Action Research Arm Test: A change of more than 5 points in either direction on the ARAT score for the affected arm.
  • Any condition that precludes a high quality brain MRI scan.

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): NCT02817087


Locations
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United States, Texas
Houston Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
David Chiu, MD
The Methodist Hospital Research Institute
Seraya Medical Systems, LLC
Investigators
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Principal Investigator: David Chiu, MD The Methodist Hospital Research Institute
  Study Documents (Full-Text)

Documents provided by David Chiu, MD, The Methodist Hospital Research Institute:
Informed Consent Form  [PDF] May 8, 2018

Publications:
Helekar, S.A., et al., Electromyographic motor-evoked potentials elicited by transcranial magnetic stimulation with rapidly moving permanent magnets mounted on a multisite stimulator cap, in 2013 Neuroscience Meeting Planner. 2013, Society for Neuroscience: San Diego, CA.
S. A. Helekar and H. U. Voss,

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Responsible Party: David Chiu, MD, Principal Investigator/Sponsor-Investigator, The Methodist Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02817087    
Other Study ID Numbers: Pro00014213
First Posted: June 29, 2016    Key Record Dates
Results First Posted: October 5, 2020
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by David Chiu, MD, The Methodist Hospital Research Institute:
Stroke
chronic ischemic stroke
cerebrovascular accident (CVA)
ischaemic stroke
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases