N/A
N=31
Multifocal Brain Magnetic Stimulation in Chronic Ischemic Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02817087 ↗Enrolled (actual)
31
Serious AEs
12.9%
Results posted
Oct 2020
Primary outcome: Primary: Changes in Brain Activation — 48.5; -30 voxels
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- repetitive Transcranial Magnetic Stimulation -On (Device); repetitive Transcranial Magnetic Stimulation -Off (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- David Chiu, MD
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Brain Activation |
48.5; -30 | — |
| SECONDARY Fugl-Meyer Motor Arm Score |
2.5; 2.0 | — |
| SECONDARY ARAT (Action Research Arm Test) |
0; 0 | — |
| SECONDARY Hand Dynamometer |
1.8; 0 | — |
| SECONDARY Pinch Dynamometer Score |
.17; .33 | — |
| SECONDARY TUG (Timed Up and Go Test) |
.04; 0 | — |
| SECONDARY National Institutes of Health Stroke Scale (NIHSS) |
0; 0 | — |
Summary
Transcranial magnetic stimulation for post-stroke upper-body motor deficits.
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.
Data sourced from ClinicalTrials.gov (NCT02817087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.