High-Frequency Repetitive Transcranial Magnetic Stimulation for Cognitive Improvement in Patients With Post-Stroke Cognitive Impairment
Efficacy of High-Frequency Repetitive Transcranial Magnetic Stimulation in Patients With Post-Stroke Cognitive Impairment: A Randomized Controlled Trial
1 other identifier
interventional
40
1 country
1
Brief 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 on patients with post-stroke cognitive impairment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2026
CompletedFirst Submitted
Initial submission to the registry
April 14, 2026
CompletedFirst Posted
Study publicly available on registry
April 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
April 23, 2026
April 1, 2026
1.2 years
April 14, 2026
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
Study Arms (2)
the control group
SHAM COMPARATORThe control group will undergo rTMS sham stimulation therapy combined with conventional rehabilitation treatment, using a sham stimulation coil.
The rTMS stimulation group
EXPERIMENTALThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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;
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Qilu Hospital of Shandong University
Jinan, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- treatment implementers（repetitive transcranial magnetic stimulation）
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
April 14, 2026
First Posted
April 23, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share