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

May 20, 2024 updated by: The Second Affiliated Hospital of Dalian Medical University

The Second Hospital of Dalian Medical University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ren

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • DaLian, Liaoning, China, 116021
        • Completed
        • Department of Rehabilitation Medicine, the Second Hospital of Dalian Medical University
      • Dalian, Liaoning, China, 116021
        • Recruiting
        • Lily
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: common group routine training
Conventional rehabilitation
Other: Routine treatment
Both groups were given routine treatment
Other Names:
  • Routine medical treatment
  • basic rehabilitation training
  • individualized cognitive training
Experimental: tDCS group
Conventional rehabilitation plus TDCS treatment
Other: Routine treatment
Both groups were given routine treatment
Other Names:
  • Routine medical treatment
  • basic rehabilitation training
  • individualized cognitive training
Other: Transcranial Direct Current Stimulation
The common group routine training used sham TDCS stimulation, and the experimental group used real TDCS stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BDNF
Time Frame: 2 weeks
Plasma BDNF was determined by elisa
2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Dalian Medical University

Investigators

  • Study Director: Yongmei Jiang, Department of Rehabilitation Medicine, the Second Hospital of Dalian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

April 23, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDNF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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