Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT03845595
Eligibility Criteria:
Inclusion Criteria:
* Forty ischemic hemiparetic stroke patients aging between 50-65 years.
* Patients with first ever ischemic stroke in the territory of the middle cerebral artery (MCA) confirmed by physician with non-contrast computed tomographic (CT) or magnetic resonance imaging (MRI) scans of the brain.
* Mild to moderate motor impairment verified according to (National Institutes of Health Stroke Scale (NIHSS)-motor arm score of 1 to 15, and modified Ashworths Scale (MAS) (1 or 1+)
* Time from onset of symptoms 3 to 6 months.
* Stable vital signs with clear consciousness and proper cooperation with assessment and treatment.
* Successful measurement of the Active motor threshold (AMT) from the 'motor hot spot' of the contralesional and the ipsilesional primary motor cortex (M1) with the election of the contralateral first dorsal interosseous (FDI) muscle .
* The medical ethical committee from faculty of physical therapy, Cairo university approved the project of the study.
* All the patients or their families were given their written consent form.
Exclusion Criteria:
* Patients who underwent surgical management including intravascular surgery or administration of tissue plasminogen activator .
* Patients with aphasia or apparent cognitive deficits ( eg, hand apraxia, unilateral spatial neglect) , visual field deficits or any psychiatric disorders or disturbed consciousness.
* Patients with serious general complications requiring intensive medical management (eg, pneumonia severe internal carotid artery stenosis or bilateral cerebrovascular lesion, heart failure, urinary tract infection, or malnutrition state)
* severe chronic or neurological diseases ( eg, shoulder pain; joint deformity or complete paralysis of the affected upper limb) .
* Any contraindications for rTMS in the guidelines (eg, patients with metal within the brain, such as clips for aneurysms, patients with a cardiac pacemaker, pregnant women, or a history of seizures or epilepsy).
* Use of any drugs that could have an effect on cortical excitability (eg, Anti-epileptic drugs).
* Patients previously underwent any type of treatments using transcranial magnetic stimulation.
* Refusal to sign the informed consent or could not carry out training or cooperate with assessments.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
65 Years
Study:
NCT03845595
Study Brief:
Protocol Section:
NCT03845595