About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
occupational therapy
Behavioraloccupational therapy (especially cognitive therapy) 40min a day for 5 days
real tACS
Other interventionreal theta-gamma CFC tACS for 40min a day for 5 days during cognitive therapy
sham tACS
Other interventionsham theta-gamma CFC tACS for 40min a day for 5 days during cognitive therapy
Treatment groups
Trial outcomes
Primary outcomes
n-back task accuracy rate
n-back task record accuracy rate
n-back task reaction time
n-back task record reaction time
function connectivity during n-back task
n-back task with fNIRS to record Oxy-Hb Concentration
Verbal fluency test(VFT)accuracy rate
VFT task record accuracy rate
Secondary outcomes
Montreal Cognitive Assessment(MoCA)
MoCA scale(score 0-30, the higher score means the better function)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ke Dong, MD
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: