StrokeNCT07573501
Dual-site Cross-frequency Coupled Transcranial Electrical Stimulation Modulates Working Memory of Patients With Post-stroke Cognitive Impairment
A study testing occupational therapy and real tACS in people with Stroke and Cognition Disorders, run by Ke Dong, MD at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke, Cognition Disorders
- What is being tested?
- occupational therapy and real tACS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 PSCI by the MoCA scale;
- Able to cooperate in completing the speech repetition test;
- Normal hearing.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
About this study
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
- Conditions
- Stroke, Cognition Disorders
- Being tested
- occupational therapy, real tACS, sham tACS
- Medical subject headings
- Stroke, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occupational therapyBehavioural
occupational therapy (especially cognitive therapy) 40min a day for 5 days
real tACSOther
real theta-gamma CFC tACS for 40min a day for 5 days during cognitive therapy
sham tACSOther
sham theta-gamma CFC tACS for 40min a day for 5 days during cognitive therapy
| Study group | Role | What they receive |
|---|---|---|
| real tACS | Experimental | Not described Receives: Behavioral: occupational therapy; Other: real tACS |
| sham tACS | Sham comparator | Not described Receives: Behavioral: occupational therapy; Other: sham tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
n-back task accuracy rate
n-back task record accuracy rate
Measured: Baseline and 5-days
n-back task reaction time
n-back task record reaction time
Measured: Baseline and 5-days
function connectivity during n-back task
n-back task with fNIRS to record Oxy-Hb Concentration
Measured: Baseline and 5-days
Verbal fluency test（VFT）accuracy rate
VFT task record accuracy rate
Measured: Baseline and 5-days
Verbal fluency test（VFT）reaction time
VFT task record reaction time
Measured: Baseline and 5-days
function connectivity during Verbal fluency test（VFT）
VFT task with fNIRS to record Oxy-Hb Concentration
Measured: Baseline and 5-days
Secondary outcomes (1)
Montreal Cognitive Assessment(MoCA)
MoCA scale(score 0-30, the higher score means the better function)
Measured: Baseline and 5-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ke Dong, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ke Dong, MD, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573501
- Sponsor's protocol ID
- Nos.82302848b
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-site Cross-frequency Coupled Transcranial Electrical Stimulation Modulates Working Memory of Patients With Post-stroke Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07573501
- Acronym / sponsor ID
- Nos.82302848b
- Conditions
- Stroke, Cognition Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ke Dong, MDUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real tACS | Experimental | Behavioral: occupational therapy, Other: real tACS |
| sham tACS | Sham comparator | Behavioral: occupational therapy, Other: sham tACS |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 PSCI by the MoCA scale;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| occupational therapyoccupational therapy (especially cognitive therapy) 40min a day for 5 days | Behavioural | real tACS, sham tACS |
| real tACSreal theta-gamma CFC tACS for 40min a day for 5 days during cognitive therapy | Other | real tACS |
| sham tACSsham theta-gamma CFC tACS for 40min a day for 5 days during cognitive therapy | Other | sham tACS |
Primary outcome
n-back task accuracy rate
Time frame: Baseline and 5-days
n-back task record accuracy rate
n-back task reaction time
Time frame: Baseline and 5-days
n-back task record reaction time
function connectivity during n-back task
Time frame: Baseline and 5-days
n-back task with fNIRS to record Oxy-Hb Concentration
Verbal fluency test（VFT）accuracy rate
Time frame: Baseline and 5-days
VFT task record accuracy rate
Verbal fluency test（VFT）reaction time
Time frame: Baseline and 5-days
VFT task record reaction time
function connectivity during Verbal fluency test（VFT）
Time frame: Baseline and 5-days
VFT task with fNIRS to record Oxy-Hb Concentration
1 secondary outcome
Montreal Cognitive Assessment(MoCA)
Time frame: Baseline and 5-days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing occupational therapy and real tACS in people with Stroke and Cognition Disorders, run by Ke Dong, MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingting Li (+86 13560365827, lijt53@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
n-back task accuracy rate (time frame: Baseline and 5-days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.