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

Official title

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

Overview

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.

Interventions

• 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.
• 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,

Primary outcome measures

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Qilu Hospital of Shandong University — Jinan

Identifiers

NCT: NCT07546877 · KYLL-2025-08-013-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗