Clinical trial NCT06386614: Effect of Frontal Transcranial Direct Current Stimulation on BDNF in Stroke Patients With Cognitive Impairment
Official title: The Second Hospital of Dalian Medical University
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: The Second Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: BDNF
timeFrame: 2 weeks
Secondary outcomes:
measure: Cognitive function level
timeFrame: 2 weeks
measure: Executive function level
timeFrame: 2 weeks
measure: Memory function level
timeFrame: 2 weeks
Other outcomes:
Locations:
city: DaLian
country: China
facility: Department of Rehabilitation Medicine, the Second Hospital of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: Lily
state: Liaoning
Study officials:
affiliation: Department of Rehabilitation Medicine, the Second Hospital of Dalian Medical University
name: Yongmei Jiang
role: STUDY_DIRECTOR
References: