Tokyo, March 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060866) titled 'Understanding post-stroke spasticity using neurophysiological testing and ultrasound-based muscle assessments' on March 7.

Study Type: Observational

Primary Sponsor: Institute - Tokyo Bay Rehabilitation Hospital

Condition: Condition - Stroke (ischemic stroke or intracerebral hemorrhage) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To characterize post-stroke spasticity by examining relationships between clinical spasticity scales, neurophysiological measures, and ultrasound-derived muscle/tissue properties. Basic objectives2 - Others

Eligibility: Age-lower limit - 50 years-old = Gender - Male and Female Key inclusion criteria - First-ever stroke (ischemic stroke or intracerebral hemorrhage) Age 50-85 years Key exclusion criteria - Uncontrolled hypertension or hypotension No motor paresis History of other central nervous system disorders History of fracture or peripheral neuropathy in the affected limb Complete sensory loss in the affected limb Severe peripheral arterial disease Severe systemic medical comorbidity Severe cognitive impairment/higher brain dysfunction or severe psychiatric disorder History of traumatic brain injury, brain tumor, bilateral hemispheric lesions, cerebellar/brainstem lesions, or subarachnoid hemorrhage (including epilepsy/seizures, hydrocephalus, or surgical clipping) Chronic headache Use of medications known to lower the seizure threshold (e.g., tricyclic antidepressants, maprotiline, theophylline, methylphenidate, ketamine, clozapine, zotepine) Current use of antiseizure medications (antiepileptic drugs) Recent adjustment of antipsychotics or hypnotics Alcohol or caffeine abuse, or current withdrawal Implanted electronic/metal devices incompatible with neurophysiological testing (e.g., pacemaker/ICD, CSF shunt, aneurysm clip) Use of antispastic medications or botulinum toxin type A injection within the past 3 months Not approved for participation by the treating physician Target Size - 30

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2023 Year 10 Month 20 Day Date of IRB - 2023 Year 10 Month 20 Day Anticipated trial start date - 2026 Year 03 Month 07 Day Last follow-up date - 2028 Year 10 Month 20 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069617

Disclaimer: Curated by HT Syndication.