Stroke Clinical Trial
Official title:
Development and Efficacy Evaluation of Individualized rTMS Protocol for Stroke Recovery
NCT number | NCT03828435 |
Other study ID # | 104-2292A3 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | December 2019 |
This study aims to develop individualized therapeutic protocol to improve stroke recovery and fits the scheme of Mechanisms, biomarkers, and treatment strategies for stroke, aging, and Parkinson's disease by advanced EEG analysis and transcranial magnetic stimulation technique.
Status | Recruiting |
Enrollment | 170 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility |
Inclusion Criteria: - first-ever stroke - in subacute stage (between 1-3 months after stroke onset) - monohemispheric ischemic stroke - able to follow the command of the shoulder flexion - mild to moderate paresis in the upper limb (the motor arm score of National Institute of Health Stroke Scale (NIHSS) = 1 & 2 out of 4, where 4 = no movement) Exclusion Criteria: - being less than 20 years or over 75 years of age - history of seizures or epileptiform discharges on electroencephalogram (EEG) - pregnancy - aphasia, apraxia, and concomitant neurological diseases or other severe medical diseases (e.g., sepsis, malignancy, hepatic or renal failure). - having a pacemaker, an implanted medication pump, a metal plate in the skull, or metal objects inside the eye or skull (for example after brain surgery or a shrapnel wound) - taking tricyclic antidepressants, neuroleptic agents and other drugs that lower the seizure threshold - Insulin dependent diabetes - Thyroid disease |
Country | Name | City | State |
---|---|---|---|
Taiwan | Ying-Zu Huang | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The changes of Fugl-Meyer Assessment of Physical Performance (FM) | a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia | upon recruitment, after 24 weeks of rehabilitation treatment | |
Primary | The changes of upper extremity performance evaluation test for the elderly (TEMPA) | a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia | upon recruitment, after 24 weeks of rehabilitation treatment | |
Primary | The changes of Wolf Motor Function Test (WMFT) | a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia | upon recruitment, after 24 weeks of rehabilitation treatment |
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