Multifocal Brain Magnetic Stimulation in Chronic Ischemic Stroke

September 9, 2020 updated by: David Chiu, MD

An Innovative Approach to Restoration of Function in Chronic Ischemic Stroke Using a New Wearable Multifocal Brain Stimulator

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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:
  • Control Group
  • sham treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One business day before treatment begins, one business day after treatment ends, up to 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One business day before treatment begins, one business day after treatment ends up to 5 weeks
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
One business day before treatment begins, one business day after treatment ends up to 5 weeks
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
One business day before treatment begins, one business day after treatment ends up to 5 weeks
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.
One business day before treatment begins, one business day after treatment ends up to 5 weeks
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.
One business day before treatment begins, one business day after treatment ends up to 5 weeks
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
One business day before treatment begins, one business day after treatment ends up to 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Chiu, MD

Collaborators

The Methodist Hospital Research Institute
Seraya Medical Systems, LLC

Investigators

  • Principal Investigator: David Chiu, MD, The Methodist Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2016

Primary Completion (Actual)

March 13, 2019

Study Completion (Actual)

March 13, 2019

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00014213

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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