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Application and mechanism study of iTBS combined with median nerve electrical stimulation in the treatment of PSCI based on multimodal evaluation method

Application and mechanism study of iTBS combined with median nerve electrical stimulation in the treatment of PSCI based on multimodal evaluation method

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121770
Enrollment
Unknown
Registered
2026-04-02
Start date
2023-11-15
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-stroke cognitive impairment

Interventions

iTBS Group:Intermittent theta burst stimulation (iTBS): stimulation of the affected dorsolateral prefrontal cortex (F3/F4), intensity at 80%-100% of motor threshold, intra-burst frequency of 50Hz, int
MNES Group:Median nerve electrical stimulation (MNES): P14 mode, frequency 40Hz, pulse width 300µs, initial intensity 14mA. Applied to the medial side of the right wrist (within 5cm range of the wrist
Combined Intervention Group:First administer median nerve electrical stimulation (MNES), followed by intermittent theta burst stimulation (iTBS). Combined with conventional rehabilitation and cognitiv
Sham Stimulation Group:Sham iTBS: the coil is rotated 90° so that the side of the coil contacts the scalp (patients hear noise but no effective stimulation is delivered). Combined with conventional re

Sponsors

Xuzhou Rehabilitation Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis of stroke meets the diagnostic criteria outlined in 2019 by the Neurology Branch of the Chinese Medical Association, the Cerebrovascular Disease Group of the Neurology Branch of the Chinese Medical Association, and the diagnostic criteria for various major cerebrovascular diseases in China. 2. Age range from 40 to 80 years old, all underwent cranial CT and MRI examinations. 3. After MoCA screening, a score of <26 was diagnosed as cognitive impairment with a course of less than 1 year. 4. Having sufficient visual and auditory discrimination to undergo neuropsychological tests and various cognitive assessments. 5. Approved by the ethics committee, the subjects and/or guardians have informed consent and signed a consent form.

Exclusion criteria

Exclusion criteria: 1. Exclude patients with a history of other brain diseases, such as traumatic brain injury, progressive supranuclear palsy, epilepsy, chronic subdural hematoma, Huntington's disease, normal pressure hydrocephalus, brain infection, brain tumor, or known brain structural abnormalities. 2. Exclude patients with a history of neurodegenerative diseases, congenital or hereditary diseases. Excluding cognitive impairment caused by cerebrovascular factors such as AD, Parkinson's disease, and Louis body dementia. 3. Exclude patients with cognitive impairment caused by liver, kidney, thyroid, and other systemic diseases, anemia, malnutrition, and other reasons. Excluding patients with consciousness disorders, severe neurological deficits, inability to take care of themselves, and severe dementia who are unable to complete the scale test. 4. (1) Excluding patients who are unable to complete the scale test due to hearing, vision, and language impairment, as well as those who have a history of alcohol or drug abuse or dependence on alcohol or drugs within the past 2 years. 5. Excluding pseudodementia caused by various other reasons. 6. Researchers believe that subjects who cannot comply with the research procedure. 7. Intracranial metal implants, magnetic films, pacemakers, etc. 8. Personal or family history of epilepsy and mental illness (including febrile seizures during infancy). 9. Pregnancy.

Design outcomes

Primary

MeasureTime frame
Lohman Occupational Therapy Cognitive Assessment (LOTCA) Score;

Secondary

MeasureTime frame
Ratio of N-acetylaspartate to creatine (NAA/Cr) and choline to creatine (Cho/Cr) in the brain assessed by 1H-MRS;P300 Latency and Amplitude Measured by Auditory Oddball Paradigm;Relative Power Ratio in EEG Frequency Bands;

Countries

China

Contacts

Public ContactWang Shiyany

Xuzhou Rehabilitation Hospital

wangshiyan3669@163.com+86 18112007636

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026