Clinical trial NCT05479903: Study on the Correlation Between Neurotrophic Factors and the Condition of Stroke Patients
Official title: Clinical Study of the Relationship Between Different Interventions for Post-stroke Functional Impairment and Neurotrophic Factors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is currently the most common disabling disease, which often leads to impairment of sensory, motor, speech and psychological functions, resulting in a reduced quality of life for patients. Therefore, post-stroke functional rehabilitation, especially the rehabilitation of physical function and psychological condition, is particularly important for patients to rejoin society. Acupuncture can promote the functional recovery of patients and facilitate the rehabilitation of limb function, thus improving the quality of survival of post-stroke patients.

Neurotrophic factors are diverse, most of which are mainly derived from neuronal cells in the central nervous system and are involved in a variety of neurological functions such as cell growth, differentiation and plasticity, thus promoting recovery of multiple functions after stroke. Many studies have found that different interventions affect the prognosis of stroke patients differently, e.g., long-term acupuncture increases serum levels of brain-derived neurotrophic factor in stroke patients and also has better outcomes than controls in post-stroke neurological recovery and the development of post-stroke psychiatric disorders.

This study investigated the effects of different therapeutic measures on patients' functional recovery and neurotrophic factors by setting up a controlled and blinded trial design, which could not only provide clinical evidence for the effectiveness of relevant therapeutic measures, but also verify the clinical value of certain neurotrophic factors (e.g., predicting outcome, assessing condition, and preventing adverse events).


Eligibility criteria: Inclusion Criteria:

* Symptom recognition to admission ≤ 72 hours
* Clear imaging evidence
* Diagnosis of spontaneous cerebral hemorrhage by an immobilized physician according to relevant guidelines; pre-onset mRS score ≤ 1

Exclusion Criteria:

* This onset was caused by traumatic and violent factors
* History of previous intracranial surgery
* Previous cerebrovascular accident
* Previous speech disorders and limb movement disorders
* Participation in other trials in the last three months.

Primary outcomes:
measure: modified rankin scale
timeFrame: Change of the score of modified rankin scale from Baseline at 1 week after onset of disease
measure: modified rankin scale
timeFrame: Change of the score of modified rankin scale from Baseline at 2 weeks after onset of disease
measure: modified rankin scale
timeFrame: Change of the score of modified rankin scale from Baseline at 1 month after onset of disease
measure: modified rankin scale
timeFrame: Change of the score of modified rankin scale from Baseline at 2 months after onset of disease
measure: modified rankin scale
timeFrame: Change of the score of modified rankin scale from Baseline at 3 months after onset of disease
Secondary outcomes:
measure: Mini-mental State Examination
timeFrame: Change of the score of modified rankin scale from Baseline at 1 week, 2 weeks, 1 month, 2 months, 3 months after onset of disease
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Yongchuan Hospital of Chongqing Medical University
Study officials:
References: