stroke
Conditions
Interventions
Group1:600 pulses sham iTBS +15 minutes rest +600 pulses sham iTBS +15 minutes rest +600 pulses active iTBS
Group2:600 pulses sham iTBS +15 minutes rest +600 pulses active iTBS +15 minutes rest +600 pulses active iTBS
Group3:600 pulses active iTBS +15 minutes rest +600 pulses active iTBS +15 minutes rest +600 pulses active iTBS
Control group:600 pulses sham iTBS +15 minutes rest +600 pulses sham iTBS +15 minutes rest +600 pulses sham iTBS
Sponsors
Beijing Bo'ai Hospital, China Rehabilitation Research Center
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. First onset or previous onset without obvious sequelae (the score of Modified Rankin Scale (mRS) before stroke =1); 2. Meet the diagnostic criteria for ischemic stroke or hemorrhagic stroke. The Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China 2018 prepared by the Neurology Branch of the Chinese Medical Association and Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke» prepared by the American Heart Association/American Stroke Association are used to diagnose ischemic stroke. «Guidelines for the Diagnosis and Treatment of Cerebral Hemorrhage in China 2019»prepared by the Neurology Branch of the Chinese Medical Association and «2022 Guideline for the Management of Patients With Spontaneous Intracerebral Hemorrhage: A Guideline From the American Heart Association/American Stroke Association» prepared by the American Heart Association/American Stroke Association are used to diagnose hemorrhagic stroke.The course of disease is greater than or equal to 1 month, less than or equal to 6 months; 3. Patients aged between 35 and 75 years (including 35 and 75 years); 4. Upper limb motor dysfunction caused by unilateral cerebral stroke (Brunnstrom stage of affected hand or upper limb is between stage ? and stage ?, including stage ? and stage ?); 5. Know the test and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Neurological impairment, upper limb restriction, mutilation, joint swelling, contracture, severe pain or other hand disorders caused by stroke, brain tumor, brain trauma, fracture and other diseases caused by bilateral hemispheres or subtentorial lesions; 2. MAS scores of shoulder, elbow, wrist and finger muscle tension of the affected upper limb are all at grade 3-4; 3. Patients with pacemakers, cochlear implants or other metal foreign bodies, or any electronic equipment implanted in the body, have contraindications for MRI scanning and TMS treatment, such as claustrophobia; 4. Combined history of epilepsy (presence of at least 2 uninduced seizures more than 24 hours apart, diagnosis of epileptic syndrome, or seizures within the past 12 months); 5. Patients with severe heart, lung, liver, kidney and other systemic diseases that cannot be controlled by conventional medication were found through laboratory tests and examinations; 6. Combined with disturbance of consciousness (NIHSS 1(a) =1 score); 7. Malignant hypertension (sudden and significant increase in blood pressure, both systolic and diastolic blood pressure, often lasting above 200/130mmHg); 8. Patients with malignant tumor; Or have a life expectancy of less than one year due to causes other than stroke; 9. Patients with severe aphasia (NIHSS speech item =2 points), dyslexia (NIHSS phonology item =2 points), cognitive impairment (MMSE score =20 points), deafness, etc., and thus unable to communicate, understand or follow instructions normally, unable to cooperate with treatment and evaluation; 10. Patients with severe depression and anxiety (HAMD-17=18; HAMA score =21), or patients diagnosed with other mental disorders; 11. Patients with severe sensory disorders (NIHSS sensory items =2 points) and severe neglect (NIHSS neglecting items =2 points); 12. Patients who received Botox injection on the affected upper limb within 3 months prior to enrollment, or considered using Botox injection at any time during the study period; 13. Received neuroregulatory treatment such as TMS, transcranial electrical stimulation and transcranial focused ultrasound within 3 months before enrollment; 14. There is a history of alcohol or drug abuse; 15. There are other test abnormalities and the researchers judge that the participants are not suitable to participate in this experiment; 16. Women of childbearing age who are pregnant or planning to become pregnant; 17. Participants in other clinical research trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of upper limb motor score in Fugl-Meyer Assessment before and after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of upper limb motor score in Fugl-Meyer Assessment during follow-up;Change of the Wolf Motor Function Test score before and after treatment;Change of grip strength before and after treatment;Changes of the Modified Barthel Index scores before treatment, after treatment, and during follow-up;Changes of the Stroke Impact Scale scores before treatment, after treatment, and follow-up; | — |
Countries
China
Contacts
Public ContactZhang Hao
China Rehabilitation Research Center
Outcome results
None listed