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NCT Number: NCT07573501

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

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

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

occupational therapy

Behavioral

occupational therapy (especially cognitive therapy) 40min a day for 5 days

real tACS

Other

real theta-gamma CFC tACS for 40min a day for 5 days during cognitive therapy

sham tACS

Other

sham theta-gamma CFC tACS for 40min a day for 5 days during cognitive therapy

Primary outcomes

  1. n-back task accuracy rate

    Time frame: Baseline and 5-days

    n-back task record accuracy rate

  2. n-back task reaction time

    Time frame: Baseline and 5-days

    n-back task record reaction time

  3. function connectivity during n-back task

    Time frame: Baseline and 5-days

    n-back task with fNIRS to record Oxy-Hb Concentration

  4. Verbal fluency test(VFT)accuracy rate

    Time frame: Baseline and 5-days

    VFT task record accuracy rate

  5. Verbal fluency test(VFT)reaction time

    Time frame: Baseline and 5-days

    VFT task record reaction time

  6. function connectivity during Verbal fluency test(VFT)

    Time frame: Baseline and 5-days

    VFT task with fNIRS to record Oxy-Hb Concentration

Secondary outcomes

  1. Montreal Cognitive Assessment(MoCA)

    Time frame: Baseline and 5-days

    MoCA scale(score 0-30, the higher score means the better function)

Study contacts

Contact information is provided by the study sponsor or research team.

Hanjun Liu

CONTACT

[email protected]

+86 15920175118

Jingting Li

CONTACT

[email protected]

+86 13560365827

Sponsors and collaborators

Lead sponsor

Ke Dong, MD

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 7, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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