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

NCT06386614 | Recruiting

• 1 other identifier: BDNF
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• BDNF

  Plasma BDNF was determined by elisa

  2 weeks

Secondary Outcomes (3)

• Cognitive function level

  2 weeks

• Executive function level

  2 weeks

• Memory function level

  2 weeks

Study Arms (2)

common group routine training

SHAM COMPARATOR

Conventional rehabilitation

Other: Routine treatment

tDCS group

EXPERIMENTAL

Conventional rehabilitation plus TDCS treatment

Other: Routine treatment; Other: Transcranial Direct Current Stimulation

Interventions

Routine treatment OTHER

Both groups were given routine treatment

Also known as: Routine medical treatment, basic rehabilitation training, individualized cognitive training

common group routine training; tDCS group

Transcranial Direct Current Stimulation OTHER

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

tDCS group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Dalian Medical University: lead

Study Sites (2)

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

Dalian, Liaoning, 116021, China

COMPLETED

Lily

Dalian, Liaoning, 116021, China

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Yongmei Jiang

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

  STUDY DIRECTOR

Central Study Contacts

Yang Tu

CONTACT

18875214238; 715700399@qq.com

Ren

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: January 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)