Dual-site Cross-frequency Coupled Transcranial Electrical Stimulation Modulates Working Memory of Patients With Post-stroke Cognitive Impairment

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorKe Dong, MD

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 volunteers

Qualifiers

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

    Behavioral

    occupational therapy (especially cognitive therapy) 40min a day for 5 days

  • real tACS

    Other intervention

    real theta-gamma CFC tACS for 40min a day for 5 days during cognitive therapy

  • sham tACS

    Other intervention

    sham theta-gamma CFC tACS for 40min a day for 5 days during cognitive therapy

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: real tACSExperimental treatment 2 interventions
Group B: sham tACSSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

n-back task accuracy rate

n-back task record accuracy rate

Time frame
Baseline and 5-days
2

n-back task reaction time

n-back task record reaction time

Time frame
Baseline and 5-days
3

function connectivity during n-back task

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

Time frame
Baseline and 5-days
4

Verbal fluency test(VFT)accuracy rate

VFT task record accuracy rate

Time frame
Baseline and 5-days

Secondary outcomes

1

Montreal Cognitive Assessment(MoCA)

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

Time frame
Baseline and 5-days

Other outcomes

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: