Galantamine Improves Motor and Sensory Dysfunction in Patients With Acute Ischemic Stroke
- Conditions
- Acute Ischemic Stroke AIS
- Interventions
- Drug: Conventional treatment for acute cerebral infarction
- Registration Number
- NCT07003386
- Lead Sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Brief Summary
Although mechanical thrombectomy or thrombolytic therapy for large vessels can achieve a revascularization rate (TICI ≥2b) of over 90%, 30-50% of patients still exhibit poor functional outcomes. This phenomenon of "ineffective reperfusion" suggests that microcirculatory dysfunction plays a decisive role in post-stroke neural injury. Therefore, it is necessary to combine brain protection strategies with microcirculatory reperfusion therapy to improve the functional prognosis of stroke patients.
As an acetylcholinesterase inhibitor (AChEI), galantamine has been widely recognized for its role in improving cerebral blood flow in ischemic stroke (IS).
Galantamine has demonstrated good safety in treating sensory and motor dysfunction caused by neurological diseases or trauma. To this end, the applicant will conduct an international-standard, randomized controlled clinical trial with conventional treatment as a comparator to evaluate the efficacy of galantamine in improving motor and sensory dysfunction in patients with acute ischemic stroke (AIS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 66
- Diagnosis of acute ischemic stroke within 72h of symptom onset
- A score of 4-25 points on the National Institute of Health Stroke Scale (NIHSS)
- The mRS score before stroke is 0-1
- Patient and family members sign informed consent
- Cranial imaging examinations confirm the presence of diseases causing similar symptoms such as brain tumors, encephalitis, brain abscess, etc., or confirm hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc
- Patients with active bleeding or bleeding tendency, malignancies, severe liver (the serum level of AST and/or ALT > 2 times the upper limit of normal), or renal failure (the serum level of creatinine > 1.5 times the upper limit of normal or GFR < 40 ml/min/1.73m2)
- Elderly people with weak constitutions or patients complicated with infections
- Patients with a history of mental illness or severe dementia
- A significant history of drug or alcohol abuse
- Allergic constitution, or allergic to two or more drugs or foods
- Pregnancy, lactation, or planning to get pregnant
- Patients who are currently participating in or have participated in other clinical trials within the past 1 month
- Currently using or having used other cholinesterase inhibitor drugs within the past 3 months
- Having taken galantamine within 1 month before randomization, or being required to take galantamine for other diseases within the next 90 days
- Patients with epilepsy, hyperkinesia, mechanical intestinal obstruction, bronchial asthma, angina pectoris, bradycardia, or glaucoma
- Individuals with contraindications to MRI examination
- Individuals who are allergic to the ingredients of the administered drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Conventional treatment for acute cerebral infarction Conventional treatment for acute cerebral infarction galantamine group Galantamine Conventional treatment for acute cerebral infarction and galantamine galantamine group Conventional treatment for acute cerebral infarction Conventional treatment for acute cerebral infarction and galantamine
- Primary Outcome Measures
Name Time Method The change in NIHSS score from admission to discharge (ΔNIHSS=NIHSS score at discharge-NIHSS score at admission) 24 hours and day 10 Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits
- Secondary Outcome Measures
Name Time Method Scores assessed by Fugl-Meyer motor assessment (FMA) 24 hours,10 days Scores on the Fugl-Meyer motor assessment (FMA) range from 0 to 100,with lower scores indicating more severe the motor dysfunction
Cerebral Blood Flow 24 hours,10 days The cerebral blood flow is evaluated by MRI
Fractional anisotropy (FA) values 24 hours,10 days The fractional anisotropy (FA) values is evaluated by MRI
TNF-α 24 hours,10 days Laboratory parameters obtained through venous blood analysis
IL-6 24 hours,10 days Laboratory parameters obtained through venous blood analysis
Modified Rankin Scale (mRS) score 24 hours,10 days,90±14 days after randomization The mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
Scores assessed by Mini-Mental State Examination (MMSE) 24 hours,10 days,90±14 days after randomization The MMSE is a brief 30-point questionnaire test that is used to screen for cognitive impairment. A score greater than or equal to 25 points is effectively normal (intact). Below this, scores can indicate severe (≤9 points), moderate (10-20 points) or mild (21-24 points) cognitive impairment
Scores assessed by Montreal Cognitive Assessment (MoCA) 24 hours,10 days,90±14 days after randomization MoCA scores range between 0 and 30. Higher scores indicate a better outcome, and a score of 26 or over is considered to be normal
Trial Locations
- Locations (1)
Shanghai Yueyang Integrated Medicine Hospital
🇨🇳Shanghai, Shanghai, China