Effects of TDCS of the Frontal Lobe on Cognitive Function and BDNF in PSCI

Stroke Clinical Trial

Official title:

The Second Hospital of Dalian Medical University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06386614
• Other study ID #: BDNF
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: April 2024
• Source: The Second Affiliated Hospital of Dalian Medical University
• Contact: Yang Tu
• Phone: 18875214238
• Email: 715700399[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Routine treatment
Both groups were given routine treatment
• Transcranial Direct Current Stimulation
The common group routine training used sham TDCS stimulation, and the experimental group used real TDCS stimulation

Locations

Country	Name	City	State
China	Department of Rehabilitation Medicine, the Second Hospital of Dalian Medical University	DaLian	Liaoning
China	Lily	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BDNF	Plasma BDNF was determined by elisa	2 weeks
Secondary	Cognitive function level	Score of Mini-Mental State Examination(MMSE) and Montreal Cognitive Assessment(MoCA)	2 weeks
Secondary	Executive function level	core of The Frontal Assessment Battery(FAB)	2 weeks
Secondary	Memory function level	Score of Rivermead Behavioral Memory Test(RBMT)	2 weeks