Post-Stroke Cognitive Impairment (PSCI)NCT07546877
High-Frequency Repetitive Transcranial Magnetic Stimulation for Cognitive Improvement in Patients With Post-Stroke Cognitive Impairment
A study testing repetitive transcranial magnetic stimulation in people with Post-Stroke Cognitive Impairment (PSCI) and Repetitive Transcranial Magnetic Stimulation (rTMS), run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
To clarify the clinical efficacy of high-frequency rTMS on patients with post-stroke cognitive impairment, fNIRS and EEG techniques were used to observe the changes in brain functional activities of patients with post-stroke cognitive impairment after rTMS treatment, and to clarify the neuroregulatory effect of rTMS… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Post-Stroke Cognitive Impairment (PSCI), Repetitive Transcranial Magnetic Stimulation (rTMS), Stroke
- What is being tested?
- repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 1 Jul 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the diagnostic criteria for stroke as stipulated in the "Guidelines for the Prevention and Treatment of Stroke in China (2021 Edition)", and the initial stroke diagnosis is confirmed by cranial CT or MRI examination, and is confirmed as the initial onset;
- The disease course is 1-12 months;
- Has cognitive impairment (MoCA < 26 points, education years ≤ 12 years, add 1 point to the score result);
- Age 35-75 years old, gender not limited;
- Stable vital signs, no progressive neurological symptoms;
- No severe aphasia, visual or auditory impairment, and able to complete the research protocol;
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- Not using antidepressant drugs simultaneously;
- If using cognitive-improving drugs (such as donepezil, memantine), it should last for at least 3 weeks or more, and no dose adjustment will be made during the enrollment period;
- Voluntarily participate and sign the informed consent form.
Who cannot join
- Has a history of brain tumors, brain trauma, epilepsy or mental disorders;
- Had cognitive impairment before the stroke;
- Underwent craniotomy or had a skull defect;
- Had implanted metal or electronic devices (such as cardiac pacemakers, cochlear implants, deep brain stimulators, aneurysm clips, internal fixation devices after ventriculoperitoneal shunt surgery, etc.);
- Has other serious diseases that may affect the study;
- Pregnant women
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, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan
run SHENG, 8615069169127, shengrun2001@163.com
About this study
Official title: Efficacy of High-Frequency Repetitive Transcranial Magnetic Stimulation in Patients With Post-Stroke Cognitive Impairment: A Randomized Controlled Trial
To clarify the clinical efficacy of high-frequency rTMS on patients with post-stroke cognitive impairment, fNIRS and EEG techniques were used to observe the changes in brain functional activities of patients with post-stroke cognitive impairment after rTMS treatment, and to clarify the neuroregulatory effect of rTMS on patients with post-stroke cognitive impairment.
Read the detailed description
The experimental group will receive rTMS stimulation therapy, which involves applying high-frequency 10Hz rTMS to the patient's head for 20 minutes, once a day, for a total of 20 sessions. The control group will undergo rTMS sham stimulation therapy, using a sham stimulation coil to apply the same parameters and method of stimulation to the head. Although the sham stimulation coil has no difference in appearance and sound from the real stimulation coil, it cannot generate a real magnetic field to stimulate the brain. You need to be evaluated before the treatment begins, after 10 sessions, and 20 sessions of the treatment. The evaluation content includes: Researchers will use relevant clinical evaluation scales to conduct functional evaluations on you, and perform near-infrared and electroencephalogram brain imaging measurements.
- Conditions
- Post-Stroke Cognitive Impairment (PSCI), Repetitive Transcranial Magnetic Stimulation (rTMS), Stroke
- Being tested
- sham repetitive transcranial magnetic stimulation, repetitive transcranial magnetic stimulation
- Keywords
- randomized controlled trials, double blind
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham repetitive transcranial magnetic stimulationOther
Also called sham rTMS
The control group will undergo rTMS sham stimulation therapy combined with conventional rehabilitation treatment. They will use a sham stimulation coil, which means applying the same parameters and methods to stimulate the head. Although the sham stimulation coil has no difference in appearance and sound from the real stimulation coil, it cannot generate a real magnetic field to stimulate the brain.
repetitive transcranial magnetic stimulationDevice
The stimulation site is the dorsolateral area of the left prefrontal lobe. The "8" shape coil is placed in contact with the scalp. The frequency is 10Hz, the repetition rate is 80% rMT. The stimulation lasts for 5 seconds, with an interval of 25 seconds. A total of 40 sets of stimulation are given, with a total of 2000 pulses. The treatment lasts for 20 minutes per day, for 20 days in total. A total of 20 interventions were completed. The experimental group will receive rTMS stimulation therapy, which involves applying high-frequency 10Hz rTMS to the patients' heads for 20 minutes, followed by conventional rehabilitation treatment.
| Study group | Role | What they receive |
|---|---|---|
| the control group | Sham comparator | The control group will undergo rTMS sham stimulation therapy combined with conventional rehabilitation treatment, using a sham stimulation coil. Receives: Other: sham repetitive transcranial magnetic stimulation |
| The rTMS stimulation group | Experimental | The experimental group will receive rTMS stimulation therapy, which involves applying high-frequency 10Hz rTMS to the patients' heads for 20 minutes, followed by conventional rehabilitation treatment. Receives: Device: repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment
The total score of the Montreal Cognitive Assessment Scale (MoCA) is 30 points. The normal cut-off score is usually ≥ 26 points. To correct for the influence of educational level, if the educational duration of the subject is ≤ 12 years, 1 point will be added to their original score, with the maximum score remaining at 30 points.
Measured: Baseline, Day 10, Day 20,Evaluate the Montreal Cognitive Assessment Scale, fNIRS, Symbol-Digit Substitution Test, Shape Linking Test, Pittsburgh Sleep Quality Index, Digit Span Test, Stroop Test, Fugl-Meyer Assessment, Hamilton Depression Scale, Hamilton
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Stroke Cognitive Impairment (PSCI)Studies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wangyonghui, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546877
- Sponsor's protocol ID
- KYLL-2025-08-013-1
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High-Frequency Repetitive Transcranial Magnetic Stimulation in Patients With Post-Stroke Cognitive Impairment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07546877
- Acronym / sponsor ID
- KYLL-2025-08-013-1
- Conditions
- Post-Stroke Cognitive Impairment (PSCI), Repetitive Transcranial Magnetic Stimulation (rTMS), Stroke
- Keywords
- randomized controlled trials, double blind
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 23 Apr 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.
To clarify the clinical efficacy of high-frequency rTMS on patients with post-stroke cognitive impairment, fNIRS and EEG techniques were used to observe the changes in brain functional activities of patients with post-stroke cognitive impairment after rTMS treatment, and to clarify the neuroregulatory effect of rTMS on patients with post-stroke cognitive impairment.
Detailed description
The experimental group will receive rTMS stimulation therapy, which involves applying high-frequency 10Hz rTMS to the patient's head for 20 minutes, once a day, for a total of 20 sessions. The control group will undergo rTMS sham stimulation therapy, using a sham stimulation coil to apply the same parameters and method of stimulation to the head. Although the sham stimulation coil has no difference in appearance and sound from the real stimulation coil, it cannot generate a real magnetic field to stimulate the brain. You need to be evaluated before the treatment begins, after 10 sessions, and 20 sessions of the treatment. The evaluation content includes: Researchers will use relevant clinical evaluation scales to conduct functional evaluations on you, and perform near-infrared and electroencephalogram brain imaging measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the control group | Sham comparator | Other: sham repetitive transcranial magnetic stimulationThe control group will undergo rTMS sham stimulation therapy combined with conventional rehabilitation treatment, using a sham stimulation coil. |
| The rTMS stimulation group | Experimental | Device: repetitive transcranial magnetic stimulationThe experimental group will receive rTMS stimulation therapy, which involves applying high-frequency 10Hz rTMS to the patients' heads for 20 minutes, followed by conventional rehabilitation treatment. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Meets the diagnostic criteria for stroke as stipulated in the "Guidelines for the Prevention and Treatment of Stroke in China (2021 Edition)", and the initial stroke diagnosis is confirmed by cranial CT or MRI examination, and is confirmed as the initial onset;
- The disease course is 1-12 months;
- Has cognitive impairment (MoCA < 26 points, education years ≤ 12 years, add 1 point to the score result);
- Age 35-75 years old, gender not limited;
- Stable vital signs, no progressive neurological symptoms;
Key exclusion criteria (6 listed)
- Has a history of brain tumors, brain trauma, epilepsy or mental disorders;
- Had cognitive impairment before the stroke;
- Underwent craniotomy or had a skull defect;
- Had implanted metal or electronic devices (such as cardiac pacemakers, cochlear implants, deep brain stimulators, aneurysm clips, internal fixation devices after ventriculoperitoneal shunt surgery, etc.);
- Has other serious diseases that may affect the study;
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 |
|---|---|---|
| sham repetitive transcranial magnetic stimulationAlso: sham rTMSThe control group will undergo rTMS sham stimulation therapy combined with conventional rehabilitation treatment. They will use a sham stimulation coil, which means applying the same parameters and methods to stimulate the head. Although the sham stimulation coil has no difference in appearance and sound from the real stimulation coil, it cannot generate a real magnetic field to stimulate the brain. | Other | the control group |
| repetitive transcranial magnetic stimulationThe stimulation site is the dorsolateral area of the left prefrontal lobe. The "8" shape coil is placed in contact with the scalp. The frequency is 10Hz, the repetition rate is 80% rMT. The stimulation lasts for 5 seconds, with an interval of 25 seconds. A total of 40 sets of stimulation are given, with a total of 2000 pulses. The treatment lasts for 20 minutes per day, for 20 days in total. A total of 20 interventions were completed. The experimental group will receive rTMS stimulation therapy, which involves applying high-frequency 10Hz rTMS to the patients' heads for 20 minutes, followed by conventional rehabilitation treatment. | Device | The rTMS stimulation group |
Primary outcome
Montreal Cognitive Assessment
Time frame: Baseline, Day 10, Day 20,Evaluate the Montreal Cognitive Assessment Scale, fNIRS, Symbol-Digit Substitution Test, Shape Linking Test, Pittsburgh Sleep Quality Index, Digit Span Test, Stroop Test, Fugl-Meyer Assessment, Hamilton Depression Scale, Hamilton
The total score of the Montreal Cognitive Assessment Scale (MoCA) is 30 points. The normal cut-off score is usually ≥ 26 points. To correct for the influence of educational level, if the educational duration of the subject is ≤ 12 years, 1 point will be added to their original score, with the maximum score remaining at 30 points.
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 23 Apr 2026.
- Individual participant dataSharing planned: No
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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 repetitive transcranial magnetic stimulation in people with Post-Stroke Cognitive Impairment (PSCI) and Repetitive Transcranial Magnetic Stimulation (rTMS), run by Qilu Hospital of Shandong University 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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 Apr 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 RUN SHENG (8615069169127, shengrun2001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (time frame: Baseline, Day 10, Day 20,Evaluate the Montreal Cognitive Assessment Scale, fNIRS, Symbol-Digit Substitution Test, Shape Linking Test, Pittsburgh Sleep Quality Index, Digit Span Test, Stroop Test, Fugl-Meyer Assessment, Hamilton Depression Scale, Hamilton). 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 23 Apr 2026.