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

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Other: Routine treatment; Other: Transcranial Direct Current Stimulation

• Registration Number: NCT06386614
• Lead Sponsor: The Second Affiliated Hospital of Dalian Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-26
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tDCS group	Transcranial Direct Current Stimulation	Conventional rehabilitation plus TDCS treatment
tDCS group	Routine treatment	Conventional rehabilitation plus TDCS treatment
common group routine training	Routine treatment	Conventional rehabilitation

Primary Outcome Measures

Name	Time	Method
BDNF	2 weeks	Plasma BDNF was determined by elisa

Secondary Outcome Measures

Name	Time	Method
Cognitive function level	2 weeks	Score of Mini-Mental State Examination(MMSE) and Montreal Cognitive Assessment(MoCA)
Executive function level	2 weeks	core of The Frontal Assessment Battery（FAB）
Memory function level	2 weeks	Score of Rivermead Behavioral Memory Test（RBMT）

Trial Locations

Locations (2)

Department of Rehabilitation Medicine, the Second Hospital of Dalian Medical University; 🇨🇳 DaLian, Liaoning, China

Lily; 🇨🇳 Dalian, Liaoning, China