Stroke, Acute Clinical Trial
Official title:
Comparison Between the Effect of Unihemispheric and Bihemispheric Transcranial Direct Current Stimulation on Spasticity and Motor Outcome in Subacute Ischemic Stroke Patients: as Add on Therapy
NCT number | NCT04770363 |
Other study ID # | 0106522 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 1, 2021 |
Est. completion date | June 20, 2021 |
Verified date | June 2021 |
Source | Alexandria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized clinical trial to study the effect of tDCS in participants with subacute ischemic stroke, the study participants will be randomly assigned into three groups; bihemispheric, unihemispheric and sham group.
Status | Completed |
Enrollment | 36 |
Est. completion date | June 20, 2021 |
Est. primary completion date | May 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Those patients had stroke in the last 3-6 months. - Subcortical stroke of middle cerebral artery (MCA), caused unilateral hemiplegia. - National institute of health stroke scale (NIHSS) motor deficits section with score 2 to 15. Exclusion Criteria: - Patient with second onset of stroke or history of Transient ischemic attack (TIA) - Metallic Implant or heart pacemakers. - Primary cerebral or subarachnoid hemorrhagic stroke. - Seizure or epilepsy or history of epilepsy at the family. - Intracranial abscess or brain tumor. - Cardiovascular disease myocardial infarction, heart failure (unstable cardiac status). - Atrial Fibrillation or paroxysmal AF in the last 30 days. - Congenital heart diseases. - Presence of any other neurological or psychiatric disorder. - Cognitive/consciousness disorders. - Oher conditions should be excluded (e.g. tumor, cancer, rheumatologic, Lung disease related to infection, renal/ hepatic diseases, deep venous thrombosis and autoimmune diseases). - Speech disorders (Dysarthria & Aphasia). - NIH Stroke score above 25, will be excluded. - Patients who underwent thrombolytic therapy or any vascular interventions. |
Country | Name | City | State |
---|---|---|---|
Egypt | Ethics Committee - Alexandria Faculty of Medicine | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Alexandria University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fugl-Meyer Assessment (FMA) | To assess the upper and lower extremities, motor and sensory recovery assessment.
Maximal attainable score is 226, means a good and functional physical state. |
1 Month | |
Primary | Modified Ashworth Scale (MAS) | To assess the spasticity within the upper and lower extremities, score ranges from 0-4 with 5 choices. 0 indicates no resistance and 4 indicates rigidity. Higher scores indicate worse outcome. | 1 Month | |
Primary | Brain-Derived Neurotrophic Factor (BDNF) concentration | is assessed pre and post-treatment for all of the participants using (ELISA) molecular test, the difference between pre and post-treatment will be only assessed, no normal range is quantified. | 1 Month | |
Secondary | The National Institutes of Health Stroke Scale, NIH Stroke Scale (NIHSS) | to objectively assess the impairment caused by a stroke, score ranges from 0-42. Higher scores indicate worse outcome and severity. 0 is normal state of any participant. | Assessed for one time during participant recruitment | |
Secondary | Berg Balance Scale | To assess the body balance and risk of fall within the upper and lower extremities, The test is scored using a 5-point ordinal scale (0-4) with detailed descriptors for each score. 0 indicates inability to obtain the task and 4 ability to fully obtain the task. Higher scores indicate good outcome. The total score ranges from 0 to 56. | 1 Month |
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