High-frequency magnetic brain stimulation to improve thinking after stroke

Efficacy of High-Frequency Repetitive Transcranial Magnetic Stimulation in Patients With Post-Stroke Cognitive Impairment: A Randomized Controlled Trial

This study will test whether daily high-frequency (10 Hz) rTMS can improve thinking and memory in adults 35–75 years old who have cognitive problems 1–12 months after a first stroke.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 35 Years to 75 Years
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (Academic / other)
• Locations: 1 site (Jinan)
• Trial ID: NCT07546877 on ClinicalTrials.gov

What this trial studies

Participants are randomly assigned to receive either real high-frequency (10 Hz) repetitive transcranial magnetic stimulation (rTMS) or a sham coil that looks and sounds the same but does not produce a magnetic field. Treatment is delivered 20 minutes a day for 20 sessions, with clinical cognitive scales and brain imaging (fNIRS and EEG) recorded before treatment, after 10 sessions, and after 20 sessions. The team uses a double-blind, controlled design so neither participants nor raters know who receives real stimulation. Outcomes focus on changes in cognitive function and brain functional activity measures.

Who should consider this trial

Good fit: Adults aged 35–75 with a first stroke 1–12 months earlier who have cognitive impairment (MoCA < 26, adjusted for education), stable vital signs, and the ability to complete testing are the ideal candidates.

Not a fit: People with a history of brain tumors or brain trauma, severe communication or sensory impairments, progressive neurological symptoms, or other contraindications to rTMS are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the intervention could improve post-stroke cognitive function and offer a non-drug option to help recovery of thinking and daily functioning.

How similar studies have performed: Prior randomized trials of rTMS for post-stroke cognitive problems have shown promising but mixed results, so this approach has some supporting evidence but is not yet definitive.

Eligibility criteria

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

Where this trial is running

Jinan

• Qilu Hospital of Shandong University — Jinan, China (Recruiting)

Study contacts

• Study coordinator: Run Sheng

Conditions Post-Stroke Cognitive Impairment; Repetitive Transcranial Magnetic Stimulation; Stroke; randomized controlled trials; double blind