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Observation of the efficacy and mechanism of repetitive transcranial magnetic iTBS combined with auricular acupoint stimulation on cognitive dysfunction after stroke

Observation of the efficacy and mechanism of repetitive transcranial magnetic iTBS combined with auricular acupoint stimulation on cognitive dysfunction after stroke

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076109
Enrollment
Unknown
Registered
2023-09-25
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-10-03

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

Conditions

stroke

Interventions

Ear Needle group:auricular stimulation
iTBS group:Repetitive transcranial magnetic iTBS
iTBS Ear Needle group:Repetitive transcranial magnetic iTBS combined with auricular stimulation

Sponsors

Shanghai Second Rehabilitation Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: ? Voluntary participation, the subject can fully understand and cooperate with this study and willing to sign the consent form, if the subject is unable to sign due to hemiplegia on the side of the lee hand, the informed consent form can be signed on behalf of the subject by his/her authorized delegate after obtaining his/her consent; ? The first occurrence of stroke, or the previous occurrence of lacunar cerebral infarction without the existence of sequelae; ? Meet the diagnostic criteria for stroke as revised by the 6th National Academic Conference on Cerebrovascular Disease and confirmed by cranial CT or MRI. ? Duration of the disease was 1 week-6 months, age was between 20 and 80 years old, vital signs were stable, there was no recurrent stroke event, and the MMSE score was <24 points; ? Subjects with grade 2 sitting balance and can tolerate sitting for 30 min and can cooperate to complete the treatment;

Exclusion criteria

Exclusion criteria: ? Presence of other intracranial pathologies, such as brain tumors, traumatic brain injury, and cerebral parasitosis; (ii) Presence of intracranial metal, pacemaker, or history of epilepsy, or rTMS intolerance; ? Those with the presence of severe visual impairment, hearing impairment, or mental disorders affecting training; (iv) Those with serious complications of stroke such as limb pain, serious lung infection, etc. affecting treatment; ? Those who have serious internal diseases such as heart, liver, kidney failure, malignant tumors, gastrointestinal bleeding; (vi) Those who cannot tolerate the skin of the ear allergic to snap needles; (vii) Those who are participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment Scale;Loewenstein Occupational Therapy Cognitive Assessment Scale;

Secondary

MeasureTime frame
Mini-mental state examination;Barthel ADL;Lesion Quantification;

Countries

China

Contacts

Public ContactJiayi Xia

Shanghai Second Rehabilitation Hospital

532821681@qq.com+86 177 2148 5860

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026