The Effects of tDCS Combined With rTMS on Post-stroke Cognitive Impairment

February 1, 2024 updated by: The Second Affiliated Hospital of Dalian Medical University

The Second Hospital of Dalian Medical University

If there is a comparison group: Researchers will compare [insert groups] to see if [insert effects]

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 brain network features with functional near-infrared spectroscopy] Participants will receive conventional treatment, tDCS treatment, or rTMS treatment, or tDCS-rTMS treatment.

And then compare cognitive function and brain function.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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

Study Contact Backup

  • Name: Ren

Study Locations

  • China
    • Liaoning
      • Dalian, Liaoning, China, 116021
        • Recruiting
        • Lily
        • Contact:
          • Wuyao Pan
          • Phone Number: +18186766836

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:

  • Meet the clinical diagnostic criteria of the Expert Consensus on the Management of Cognitive Impairment after Stroke in 2021;
  • 30-80 years old, right-handed, unilateral hemiplegia;
  • Verbal expression can cooperate with the completion of the evaluation, sustained attention time is longer than 5 minutes;
  • Simple Mental State Examination Scale (MMSE) score ≤26 points; MoCA scale score < 26 points; Memory test (RMBT) score less than 21 points;
  • patients or their family agree to sign the informed consent;
  • The Ethics Committee approved the trial.

Exclusion Criteria:

  • Memory dysfunction caused by other diseases, such as Alzheimer's disease, lewy body dementia, pituitary tumor surgery, hypothyroidism, etc.;
  • There are contraindications of rTMS and tDCS for untreated intracranial aneurysms, severe epilepsy, intracranial metal, etc.
  • Patients with severe visual, cognitive or speech impairment who cannot cooperate with treatment;
  • The condition is not stable; Or other serious physical diseases.

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
Other: routine treatment
Routine medical treatment, basic rehabilitation training and individualized cognitive training
Experimental: tDCS group
tDCS
Other: routine treatment
Routine medical treatment, basic rehabilitation training and individualized cognitive training
Other: Non-invasive brain stimulation
tDCS&rTMS
Experimental: rTMS group
rTMS
Other: routine treatment
Routine medical treatment, basic rehabilitation training and individualized cognitive training
Other: Non-invasive brain stimulation
tDCS&rTMS
Experimental: Combination group
tDCS-rTMS
Other: routine treatment
Routine medical treatment, basic rehabilitation training and individualized cognitive training
Other: Non-invasive brain stimulation
tDCS&rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of brain's HbO by functional near-infrared spectroscopy
Time Frame: 2 weeks
fNIRS
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of Mini-Mental State Examination
Time Frame: 2 weeks
MMSE
2 weeks
Score of The Frontal Assessment Battery
Time Frame: 2 weeks
FAB
2 weeks
Score of Attention assessment by the digit span task
Time Frame: 2 weeks
DST
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)

November 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNIRS

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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