High-Frequency Repetitive Transcranial Magnetic Stimulation for Cognitive Improvement in Patients With Post-Stroke Cognitive Impairment

April 21, 2026 updated by: wangyonghui, Qilu Hospital of Shandong University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Jinan, China
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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;
  2. The disease course is 1-12 months;
  3. Has cognitive impairment (MoCA < 26 points, education years ≤ 12 years, add 1 point to the score result);
  4. Age 35-75 years old, gender not limited;
  5. Stable vital signs, no progressive neurological symptoms;
  6. No severe aphasia, visual or auditory impairment, and able to complete the research protocol;
  7. Not using antidepressant drugs simultaneously;
  8. 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;
  9. Voluntarily participate and sign the informed consent form.

Exclusion Criteria:

  1. Has a history of brain tumors, brain trauma, epilepsy or mental disorders;
  2. Had cognitive impairment before the stroke;
  3. Underwent craniotomy or had a skull defect;
  4. 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.);
  5. Has other serious diseases that may affect the study;
  6. Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: the control group
The control group will undergo rTMS sham stimulation therapy combined with conventional rehabilitation treatment, using a sham stimulation coil.
Other: sham repetitive transcranial magnetic stimulation
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.
Other Names:
  • sham rTMS
Experimental: The rTMS stimulation group
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: repetitive transcranial magnetic stimulation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KYLL-2025-08-013-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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