Dual-site Cross-frequency Coupled Transcranial Electrical Stimulation Modulates Working Memory of Patients With Post-stroke Cognitive Impairment

May 6, 2026 updated by: Ke Dong, MD
This clinical trial aims to explore the effect of dual-site theta-gamma cross-frequency coupled transcranial alternating current stimulation in the frontal and parietal region on the working memory ability of patients with cognitive impairment after stroke, and to evaluate the safety of this protocol. The main purpose is to answer the following question: Can dual-site cross-frequency coupled tACS in the frontal parietal region improve the performance of working memory and cognitive-motor dual tasks in stroke patients? What is its mechanism of action? Researchers will compare the effects of real cross-frequency coupled stimuli and sham stimuli to see if the real stimuli can bring better results to patients. Participants will receive 40 minutes of real or sham electrical stimulation once a day for 5 consecutive days. Clinical evaluations (cognitive scales) and fNIRS were conducted respectively before and after stimulation to record the relevant brain activities at rest and during cognitive tasks

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

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

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University

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:

  • Meeting the diagnostic criteria for hemorrhagic or ischemic stroke in the Chinese Guidelines for the Prevention and Treatment of Cerebrovascular Diseases(2nd edition), with the first onset, single hemisphere stroke, and confirmed by CT or MRI,course of diease 1-6 months;
  • Age ranging from 30 to 80 years old;
  • Native language is Mandarin or Cantonese;
  • Right-handed;
  • Diagnosed with PSCI by the MoCA scale;
  • Able to cooperate in completing the speech repetition test;
  • Normal hearing.

Exclusion Criteria:

  • Currently receiving non-invasive brain stimulation treatment;
  • Lesions involving the left DLPFC brain regions;
  • History of epilepsy, mental illness,or other neurological or mental disorders;
  • Any contraindications for transcranial electrical stimulation.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: real tACS
Behavioral: occupational therapy
occupational therapy (especially cognitive therapy) 40min a day for 5 days
Other: real tACS
real theta-gamma CFC tACS for 40min a day for 5 days during cognitive therapy
Sham Comparator: sham tACS
Behavioral: occupational therapy
occupational therapy (especially cognitive therapy) 40min a day for 5 days
Other: sham tACS
sham theta-gamma CFC tACS for 40min a day for 5 days during cognitive therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
n-back task accuracy rate
Time Frame: Baseline and 5-days
n-back task record accuracy rate
Baseline and 5-days
n-back task reaction time
Time Frame: Baseline and 5-days
n-back task record reaction time
Baseline and 5-days
function connectivity during n-back task
Time Frame: Baseline and 5-days
n-back task with fNIRS to record Oxy-Hb Concentration
Baseline and 5-days
Verbal fluency test（VFT）accuracy rate
Time Frame: Baseline and 5-days
VFT task record accuracy rate
Baseline and 5-days
Verbal fluency test（VFT）reaction time
Time Frame: Baseline and 5-days
VFT task record reaction time
Baseline and 5-days
function connectivity during Verbal fluency test（VFT）
Time Frame: Baseline and 5-days
VFT task with fNIRS to record Oxy-Hb Concentration
Baseline and 5-days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment(MoCA)
Time Frame: Baseline and 5-days
MoCA scale(score 0-30, the higher score means the better function)
Baseline and 5-days

Collaborators and Investigators

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

Sponsor

Ke Dong, MD

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 (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 22, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nos.82302848b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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