Post-Stroke Cognitive Impairment (PSCI), Repetitive Transcranial Magnetic Stimulation (rTMS), Stroke
Conditions
Keywords
randomized controlled trials, double blind
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.
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
OTHERsham 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.
DEVICErepetitive 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.
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
treatment implementers（repetitive transcranial magnetic stimulation）
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment | 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. |
Countries
China
Contacts
CONTACTRUN SHENG
Outcome results
None listed