The Effect of tDCS Combined With TMS on Cognitive Impairment and Motor Function After Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorKe Dong, MD
About this trial
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 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
Design model
Parallel
Treatments tested in this trial
occupational therapy
Behavioraloccupational therapy 1 hour a day for 7 days
real tDCS
Other interventionreal 20 minutes of tDCS once a day for 7 days
sham tDCS
Other interventionsham 20 minutes of tDCS once a day for 7 days
real TMS
Other intervention40 seconds of real TMS once a day for 7 days
sham TMS
Other intervention40 seconds of sham TMS once a day for 7 days
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: real tDCS-TMSExperimental treatment 3 interventions
Group B: sham tDCS-TMSSham comparator 3 interventions
Trial outcomes
Primary outcomes
1
n-back task accuracy rate
n-back task record accuracy rate
Time frame
Baseline and 7-days2
n-back task reaction time
n-back task record reaction time
Time frame
Baseline and 7-days3
functional connectivity during n-back task
n-back task with fNIRS to record Oxy-Hb concentration
Time frame
Baseline and 7-days4
Verbal fluency test（VFT）accuracy rate
VFT task record accuracy rate
Time frame
Baseline and 7-daysSecondary outcomes
1
Montreal Cognitive Assessment(MoCA)
MoCA scale(score 0-30, the higher score means the better function)
Time frame
Baseline and 7-days2
isokinetic muscle strength test
isokinetic muscle strength test of knee
Time frame
Baseline and 7-daysSponsors 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
Source ClinicalTrials.gov
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