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NCT Number: NCT07573475

The Effect of tDCS Combined With TMS on Cognitive Impairment and Motor Function After Stroke

This clinical trial aims to investigate whether transcranial electrical stimulation (tDCS) combined with transcranial magnetic stimulation(TMS) has an impact on the cognitive and motor functions of stroke patients, and to evaluate the safety of this protocol. The main objective is to answer the following question: Can electromagnetic combined stimulation of the left Dorsolateral prefrontal lobe(DLPFC) improve the performance of working memory, motor function and cognitively motor dual tasks in stroke patients? What is its mechanism of action? Participants will undergo a combined real or sham electromagnetic stimulation of 20 minutes of tDCS and 40 seconds of TMS once a day for 7 days. Researchers will compare the effects of real stimulation with sham stimulation to see if the real stimulation can bring better results to patients. Clinical evaluations (cognitive and motor scales) and functional Near-Infrared Spectroscopy(fNIRS) were conducted before and after stimulation to record relevant brain activities

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Mental Disorders Nervous System Diseases Neurocognitive Disorders Vascular Diseases

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 post-stroke cognitive impairment(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 1 hour a day for 7 days

real tDCS

Other

real 20 minutes of tDCS once a day for 7 days

Sham tDCS

Other

sham 20 minutes of tDCS once a day for 7 days

real TMS

Other

40 seconds of real TMS once a day for 7 days

Sham TMS

Other

40 seconds of sham TMS once a day for 7 days

Primary outcomes

  1. n-back task accuracy rate

    Time frame: Baseline and 7-days

    n-back task record accuracy rate

  2. n-back task reaction time

    Time frame: Baseline and 7-days

    n-back task record reaction time

  3. functional connectivity during n-back task

    Time frame: Baseline and 7-days

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

  4. Verbal fluency test（VFT）accuracy rate

    Time frame: Baseline and 7-days

    VFT task record accuracy rate

  5. Verbal fluency test（VFT）reaction time

    Time frame: Baseline and 7-days

    VFT task record reaction time

  6. functional connectivity during Verbal fluency test（VFT）

    Time frame: Baseline and 7-days

    VFT task with fNIRS to record Oxy-Hb concentration

Secondary outcomes

  1. Montreal Cognitive Assessment(MoCA)

    Time frame: Baseline and 7-days

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

  2. isokinetic muscle strength test

    Time frame: Baseline and 7-days

    isokinetic muscle strength test of knee

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

Official study title

The Effect of Transcranial Electrical Stimulation Combined With Transcranial Magnetic Stimulation on Cognitive Impairment and Motor Function After Stroke

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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