Effect of Frontal Transcranial Direct Current Stimulation on BDNF in Stroke Patients With Cognitive Impairment

NCT ID: NCT06386614

Last Updated: 2024-05-21

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

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-06-01

Brief Summary

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The purpose of the clinical trial is to find a treatment for stroke patients with cognitive impairment, and the main questions it aims to answer are:

* \[Search for effective treatments of cognitive impairment after stroke\]
* \[explore the relationship between BDNF level and cognitive function\] Participants will receive conventional treatment, tDCS treatment, .And then compare cognitive function and BDNF level

Detailed Description

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1. To study the therapeutic effect of transcranial direct current stimulation (tDCS) on post-stroke cognitive impairment (PSCI) by evaluating cognitive function and detecting plasma brain-derived neurotrophic factor (BDNF).
2. To explore the correlation between plasma BDNF level and cognitive function in patients with PSCI.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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common group routine training

Conventional rehabilitation

Group Type SHAM_COMPARATOR

Routine treatment

Intervention Type OTHER

Both groups were given routine treatment

tDCS group

Conventional rehabilitation plus TDCS treatment

Group Type EXPERIMENTAL

Routine treatment

Intervention Type OTHER

Both groups were given routine treatment

Transcranial Direct Current Stimulation

Intervention Type OTHER

The common group routine training used sham TDCS stimulation, and the experimental group used real TDCS stimulation

Interventions

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Routine treatment

Both groups were given routine treatment

Intervention Type OTHER

Transcranial Direct Current Stimulation

The common group routine training used sham TDCS stimulation, and the experimental group used real TDCS stimulation

Intervention Type OTHER

Other Intervention Names

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Routine medical treatment basic rehabilitation training individualized cognitive training

Eligibility Criteria

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Inclusion Criteria

* (1)Stroke patients with CT or MRI imaging evidence, among which ischemic stroke met the diagnostic criteria of Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, and cerebral hemorrhage diseases met the diagnostic criteria of Chinese Guidelines for the Diagnosis and Treatment of Cerebral hemorrhage 2019; (2) There are symptoms related to cognitive dysfunction; Cognitive dysfunction was assessed by rehabilitation physicians. According to the MoCA evaluation standard,MoCA score ≤26 points; according to the MMSE evaluation standard, illiteracy score ≤17 points; primary school education level ≤20 points; secondary school education (including secondary school) level ≤22 points; college education (including junior college) level ≤23 points; (3)Age range 40-80 years old; (4) no obvious aphasia, speech expression and attention can cooperate with the completion of evaluation and treatment; (5)The patient or the patient's family members read and agree to sign the informed consent.

Exclusion Criteria

* (1) Patients with severe diseases, such as malignant arrhythmia, acute myocardial infarction and acute heart failure, who cannot tolerate rehabilitation treatment; (2) Patients with untreated intracranial aneurysms, severe epilepsy, and intracranial metals who cannot receive tDCS treatment; (3) Non-PSCI patients with cognitive impairment, including patients with cognitive impairment left over from previous stroke and other organ disorders.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yongmei Jiang

Role: STUDY_DIRECTOR

Department of Rehabilitation Medicine, the Second Hospital of Dalian Medical University

Locations

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Department of Rehabilitation Medicine, the Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status COMPLETED

Lily

Dalian, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yang Tu

Role: CONTACT

18875214238

Ren

Role: CONTACT

Facility Contacts

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Yang Tu

Role: primary

18875214238

Other Identifiers

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BDNF

Identifier Type: -

Identifier Source: org_study_id

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