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Multifocal Brain Magnetic Stimulation in Chronic Ischemic Stroke

D

David Chiu, MD

Status

Completed

Conditions

Stroke

Treatments

Device: repetitive Transcranial Magnetic Stimulation -Off
Device: repetitive Transcranial Magnetic Stimulation -On

Study type

Interventional

Funder types

Other

Identifiers

NCT02817087
Pro00014213

Details and patient eligibility

About

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

Full 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.

Enrollment

38 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

38 participants in 2 patient groups

repetitive Transcranial Magnetic Stimulation -On
Active Comparator group
Description:
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.
Treatment:
Device: repetitive Transcranial Magnetic Stimulation -On
repetitive Transcranial Magnetic Stimulation -Off
Sham Comparator group
Description:
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.
Treatment:
Device: repetitive Transcranial Magnetic Stimulation -Off

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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