occupational therapy: occupational therapy 1 hour a day for 7 days
real tDCS: real 20 minutes of tDCS once a day for 7 days
sham tDCS: sham 20 minutes of tDCS once a day for 7 days
real TMS: 40 seconds of real TMS once a day for 7 days
sham TMS: 40 seconds of sham TMS once a day for 7 days
Study summary
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
Eligibility
Sex
ALL
Min age
30 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
n-back task accuracy rate — Baseline and 7-days n-back task record accuracy rate
n-back task reaction time — Baseline and 7-days n-back task record reaction time
functional connectivity during n-back task — Baseline and 7-days n-back task with fNIRS to record Oxy-Hb concentration
Verbal fluency test(VFT)accuracy rate — Baseline and 7-days VFT task record accuracy rate
Verbal fluency test(VFT)reaction time — Baseline and 7-days VFT task record reaction time
functional connectivity during Verbal fluency test(VFT) — Baseline and 7-days VFT task with fNIRS to record Oxy-Hb concentration
Trial sites (1)
Facility
City
Region
Status
Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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