Study on the Correlation Between Neurotrophic Factors and the Condition of Stroke Patients

Stroke Clinical Trial

Official title:

Clinical Study of the Relationship Between Different Interventions for Post-stroke Functional Impairment and Neurotrophic Factors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05479903
• Other study ID #: 2021kelunshen110
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2022
• Source: Chongqing Medical University
• Contact: Lingcong Li, M.S. in Medicine
• Phone: +8602385381636
• Email: molly2816[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• acupuncture
Manual acupuncture or electro-acupuncture by experienced acupuncturists for patients

Behavioral:
• computerized cognitive training system
One-on-one cognitive training by an experienced cognitive therapist, combined with an existing computerized cognitive training system
• aerobic exercise
Patients are trained by experienced physical therapists with the help of elastic bands and physical therapy devices
• tranditional cognitive training
One-on-one cognitive training with an experienced cognitive therapist, combined with traditional cognitive training methods (e.g., balls, cards, counting, daily conversation, etc.)

Other:
• Conventional treatment
Treatment of underlying disease and stroke according to guidelines, as well as necessary care and rehabilitation

Locations

Country	Name	City	State
China	Yongchuan Hospital of Chongqing Medical University	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified rankin scale	The mrs (modified rankin scale) is a scale used to assess the patient's ability to care for himself/herself, which is composed of independent walking ability, self-perceived symptoms, and ability to control bowel and urine.Assessment results range from 0-6 points,a higher score means a worse ending	Change of the score of modified rankin scale from Baseline at 1 week after onset of disease
Primary	modified rankin scale	The mrs (modified rankin scale) is a scale used to assess the patient's ability to care for himself/herself, which is composed of independent walking ability, self-perceived symptoms, and ability to control bowel and urine.Assessment results range from 0-6 points,a higher score means a worse ending	Change of the score of modified rankin scale from Baseline at 2 weeks after onset of disease
Primary	modified rankin scale	The mrs (modified rankin scale) is a scale used to assess the patient's ability to care for himself/herself, which is composed of independent walking ability, self-perceived symptoms, and ability to control bowel and urine.Assessment results range from 0-6 points,a higher score means a worse ending	Change of the score of modified rankin scale from Baseline at 1 month after onset of disease
Primary	modified rankin scale	The mrs (modified rankin scale) is a scale used to assess the patient's ability to care for himself/herself, which is composed of independent walking ability, self-perceived symptoms, and ability to control bowel and urine.Assessment results range from 0-6 points,a higher score means a worse ending	Change of the score of modified rankin scale from Baseline at 2 months after onset of disease
Primary	modified rankin scale	The mrs (modified rankin scale) is a scale used to assess the patient's ability to care for himself/herself, which is composed of independent walking ability, self-perceived symptoms, and ability to control bowel and urine.Assessment results range from 0-6 points,a higher score means a worse ending	Change of the score of modified rankin scale from Baseline at 3 months after onset of disease
Secondary	Mini-mental State Examination	The MMSE (Mini-mental State Examination) is a scale that assesses patients' cognition in terms of calculation, orientation, memory, and recall on a scale of 0-30, which is combined with the patient's level of education to yield results for different levels of cognitive impairment.	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