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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Procedure: acupuncture; Other: Conventional treatment; Behavioral: computerized cognitive training system; Behavioral: aerobic exercise; Behavioral: tranditional cognitive training

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lingcong Li, M.S. in Medicine; Phone Number: +8602385381636; Email: molly2816@163.com

Study Locations

• China
  • Chongqing, China
    • Recruiting
    • Yongchuan Hospital of Chongqing Medical University
    • Contact: Lingcong Li, M.S. in Medicine; Phone Number: +8602385381636; Email: molly2816@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acupuncture stroke group	Procedure: acupuncture; Manual acupuncture or electro-acupuncture by experienced acupuncturists for patients; Other: Conventional treatment; Treatment of underlying disease and stroke according to guidelines, as well as necessary care and rehabilitation
Sham Comparator: sham acupuncture stroke group	Other: Conventional treatment; Treatment of underlying disease and stroke according to guidelines, as well as necessary care and rehabilitation
Placebo Comparator: no acupuncture stroke group	Other: Conventional treatment; Treatment of underlying disease and stroke according to guidelines, as well as necessary care and rehabilitation
Placebo Comparator: acupuncture healthy group	Procedure: acupuncture; Manual acupuncture or electro-acupuncture by experienced acupuncturists for patients
Experimental: computerized cognitive training group	Other: Conventional treatment; Treatment of underlying disease and stroke according to guidelines, as well as necessary care and rehabilitation; Behavioral: computerized cognitive training system; One-on-one cognitive training by an experienced cognitive therapist, combined with an existing computerized cognitive training system
Placebo Comparator: tranditional cognitive training group	Other: Conventional treatment; Treatment of underlying disease and stroke according to guidelines, as well as necessary care and rehabilitation; Behavioral: aerobic exercise; Patients are trained by experienced physical therapists with the help of elastic bands and physical therapy devices
Experimental: aerobics group	Other: Conventional treatment; Treatment of underlying disease and stroke according to guidelines, as well as necessary care and rehabilitation; Behavioral: 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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2021kelunshen110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No