Cognition Disorders, Stroke
Conditions
Brief 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
Interventions
OTHERsham tDCS
sham 20 minutes of tDCS once a day for 7 days
OTHERreal TMS
40 seconds of real TMS once a day for 7 days
OTHERsham TMS
40 seconds of sham TMS once a day for 7 days
BEHAVIORALoccupational therapy
occupational therapy 1 hour a day for 7 days
OTHERreal tDCS
real 20 minutes of tDCS once a day for 7 days
Sponsors
Ke Dong, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal fluency test（VFT）accuracy rate | Baseline and 7-days | VFT task record accuracy rate |
| functional connectivity during Verbal fluency test（VFT） | Baseline and 7-days | VFT task with fNIRS to record Oxy-Hb concentration |
| functional connectivity during n-back task | Baseline and 7-days | n-back task with fNIRS to record Oxy-Hb concentration |
| Verbal fluency test（VFT）reaction time | Baseline and 7-days | VFT task record reaction time |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment(MoCA) | Baseline and 7-days | MoCA scale(score 0-30, the higher score means the better function) |
| isokinetic muscle strength test | Baseline and 7-days | isokinetic muscle strength test of knee |
Countries
China
Contacts
CONTACTJingting Li
CONTACTHanjun Liu
Outcome results
None listed