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

NCT ID: NCT05479903

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-16

Study Completion Date

2024-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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acupuncture stroke group

Group Type EXPERIMENTAL

acupuncture

Intervention Type PROCEDURE

Manual acupuncture or electro-acupuncture by experienced acupuncturists for patients

Conventional treatment

Intervention Type OTHER

Treatment of underlying disease and stroke according to guidelines, as well as necessary care and rehabilitation

sham acupuncture stroke group

Group Type SHAM_COMPARATOR

Conventional treatment

Intervention Type OTHER

Treatment of underlying disease and stroke according to guidelines, as well as necessary care and rehabilitation

no acupuncture stroke group

Group Type PLACEBO_COMPARATOR

Conventional treatment

Intervention Type OTHER

Treatment of underlying disease and stroke according to guidelines, as well as necessary care and rehabilitation

acupuncture healthy group

Group Type PLACEBO_COMPARATOR

acupuncture

Intervention Type PROCEDURE

Manual acupuncture or electro-acupuncture by experienced acupuncturists for patients

computerized cognitive training group

Group Type EXPERIMENTAL

computerized cognitive training system

Intervention Type BEHAVIORAL

One-on-one cognitive training by an experienced cognitive therapist, combined with an existing computerized cognitive training system

Conventional treatment

Intervention Type OTHER

Treatment of underlying disease and stroke according to guidelines, as well as necessary care and rehabilitation

tranditional cognitive training group

Group Type PLACEBO_COMPARATOR

aerobic exercise

Intervention Type BEHAVIORAL

Patients are trained by experienced physical therapists with the help of elastic bands and physical therapy devices

Conventional treatment

Intervention Type OTHER

Treatment of underlying disease and stroke according to guidelines, as well as necessary care and rehabilitation

aerobics group

Group Type EXPERIMENTAL

tranditional cognitive training

Intervention Type BEHAVIORAL

One-on-one cognitive training with an experienced cognitive therapist, combined with traditional cognitive training methods (e.g., balls, cards, counting, daily conversation, etc.)

Conventional treatment

Intervention Type OTHER

Treatment of underlying disease and stroke according to guidelines, as well as necessary care and rehabilitation

Interventions

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acupuncture

Manual acupuncture or electro-acupuncture by experienced acupuncturists for patients

Intervention Type PROCEDURE

computerized cognitive training system

One-on-one cognitive training by an experienced cognitive therapist, combined with an existing computerized cognitive training system

Intervention Type BEHAVIORAL

aerobic exercise

Patients are trained by experienced physical therapists with the help of elastic bands and physical therapy devices

Intervention Type 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.)

Intervention Type BEHAVIORAL

Conventional treatment

Treatment of underlying disease and stroke according to guidelines, as well as necessary care and rehabilitation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Lingcong Li

M.S. in Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yongchuan Hospital of Chongqing Medical University

Chongqing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lingcong Li, M.S. in Medicine

Role: CONTACT

Phone: +8602385381636

Email: [email protected]

Facility Contacts

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Lingcong Li, M.S. in Medicine

Role: primary

Other Identifiers

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2021kelunshen110

Identifier Type: -

Identifier Source: org_study_id