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Multifocal Brain Magnetic Stimulation in Chronic Ischemic Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
repetitive Transcranial Magnetic Stimulation -On
repetitive Transcranial Magnetic Stimulation -Off
Sponsored by
David Chiu, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, chronic ischemic stroke, cerebrovascular accident (CVA), ischaemic stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Houston Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

repetitive Transcranial Magnetic Stimulation -On

repetitive Transcranial Magnetic Stimulation -Off

Arm Description

Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.

Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.

Outcomes

Primary Outcome Measures

Changes in Brain Activation
Change in number of active voxels in the cortical areas surrounding the lesion on functional MRI

Secondary Outcome Measures

Fugl-Meyer Motor Arm Score
Change in arm motor function Total score range is 0-66 with the higher number representing a better outcome
ARAT (Action Research Arm Test)
Change in arm and hand motor function Total score range is 0-57 with the higher number representing a better outcome
Hand Dynamometer
Change in grip strength The higher the number represents better outcome
Pinch Dynamometer Score
Change in pinch strength. The higher the number, the better the outcome.
TUG (Timed Up and Go Test)
Change in gait velocity on Timed Up and Go Test. The lower the time recorded, the better the outcome.
National Institutes of Health Stroke Scale (NIHSS)
Change in National Institutes of Health Stroke Scale (NIHSS) Total score range is 0-42 with the lower number representing a better outcome

Full Information

First Posted
March 31, 2016
Last Updated
September 9, 2020
Sponsor
David Chiu, MD
Collaborators
The Methodist Hospital Research Institute, Seraya Medical Systems, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02817087
Brief Title
Multifocal Brain Magnetic Stimulation in Chronic Ischemic Stroke
Official Title
An Innovative Approach to Restoration of Function in Chronic Ischemic Stroke Using a New Wearable Multifocal Brain Stimulator
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 27, 2016 (Actual)
Primary Completion Date
March 13, 2019 (Actual)
Study Completion Date
March 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Chiu, MD
Collaborators
The Methodist Hospital Research Institute, Seraya Medical Systems, LLC

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, chronic ischemic stroke, cerebrovascular accident (CVA), ischaemic stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Active repetitive transcranial magnetic stimulation administered through cap worn by patient under healthcare provider.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double-blind, only the care provider is aware of active treatment assignment.
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
repetitive Transcranial Magnetic Stimulation -On
Arm Type
Active Comparator
Arm Description
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.
Arm Title
repetitive Transcranial Magnetic Stimulation -Off
Arm Type
Sham Comparator
Arm Description
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.
Intervention Type
Device
Intervention Name(s)
repetitive Transcranial Magnetic Stimulation -On
Other Intervention Name(s)
transcranial magnetic stimulation (TMS), Transcranial Rotating Permanent Magnet Stimulation (TRPMS), repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain
Intervention Type
Device
Intervention Name(s)
repetitive Transcranial Magnetic Stimulation -Off
Other Intervention Name(s)
sham treatment, Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Brain Activation
Description
Change in number of active voxels in the cortical areas surrounding the lesion on functional MRI
Time Frame
One business day before treatment begins, one business day after treatment ends, up to 5 weeks
Secondary Outcome Measure Information:
Title
Fugl-Meyer Motor Arm Score
Description
Change in arm motor function Total score range is 0-66 with the higher number representing a better outcome
Time Frame
One business day before treatment begins, one business day after treatment ends up to 5 weeks
Title
ARAT (Action Research Arm Test)
Description
Change in arm and hand motor function Total score range is 0-57 with the higher number representing a better outcome
Time Frame
One business day before treatment begins, one business day after treatment ends up to 5 weeks
Title
Hand Dynamometer
Description
Change in grip strength The higher the number represents better outcome
Time Frame
One business day before treatment begins, one business day after treatment ends up to 5 weeks
Title
Pinch Dynamometer Score
Description
Change in pinch strength. The higher the number, the better the outcome.
Time Frame
One business day before treatment begins, one business day after treatment ends up to 5 weeks
Title
TUG (Timed Up and Go Test)
Description
Change in gait velocity on Timed Up and Go Test. The lower the time recorded, the better the outcome.
Time Frame
One business day before treatment begins, one business day after treatment ends up to 5 weeks
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
Change in National Institutes of Health Stroke Scale (NIHSS) Total score range is 0-42 with the lower number representing a better outcome
Time Frame
One business day before treatment begins, one business day after treatment ends up to 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Chiu, MD
Organizational Affiliation
The Methodist Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Multifocal Brain Magnetic Stimulation in Chronic Ischemic Stroke

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