Ischemic stroke
Conditions
Interventions
LF-rTMS group:Using an 8-wire coil (stimulation site: the primary motor cortex (M1) area on the healthy side of the brain), 1-Hz rTMS, with a stimulation intensity of 90% RMT, 1200 pulses per session,
then the lesioned side M1 area received sham stimulation (5-Hz rTMS, 90% RMT, 1200 pulses per session, for 20 minutes, but the coil was reversed and placed on the surface of the skull), for 20 minutes
HF-rTMS group:Healthy side sham stimulation: Use an 8-turn coil (stimulation site: healthy side M1 area), 1-Hz rTMS, stimulation intensity 90% RMT, 1200 pulses/session, for 20 minutes, but reverse the
then the M1 area on the lesion side receives HF-rTMS (5-Hz rTMS, 90% RMT, 1200 pulses/session, for 20 minutes), for 20 minutes. Once a day, 5 times a week, total treatment course 2 weeks.
LF-HF-rTMS group:Healthy side HF-rTMS: Using an 8-turn coil (stimulation area: healthy side M1 area), 1-Hz rTMS, stimulation intensity 90% RMT, 1200 pulses per session, for 20 minutes
then the lesion side M1 area received HF-rTMS (5-Hz rTMS, 90% RMT, 1200 pulses per session, for 20 minutes), for 20 minutes. Once a day, 5 times a week, total treatment course of 2 weeks.
sham group:Using the same parameters as in the (3) LF-HF-rTMS group (including the location, stimulation frequency, duration, etc.), but placing the coil vertically on the surface of the skull.
Sponsors
Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 80 years old; Infarction site located in the anterior circulation; 4. Unilateral upper limb muscle strength = 3 grade; 5. NIHSS score = 5 and = 15 at admission; ASPECT score = 6; mRS score 0-1 before onset; 6. No plan for invasive surgical treatment such as thrombectomy. 7. The patient or a legally authorized representative has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have received or are planning to receive vascular opening treatment; 2. Epilepsy-related: Have a history of epilepsy, a family history of epilepsy, or have brain diseases that may induce epilepsy; 3. Suffer from intracranial hemorrhage (cerebral parenchyma, subarachnoid, subdural, epidural), brain tumors, Parkinson's disease, dementia, or other central nervous system diseases; 4. Implant-related: Have any metal implants in the head or intracranially (such as aneurysm clips, cochlear implants, deep brain stimulation electrodes), or have electronic medical devices in the body such as pacemakers or insulin pumps; 5. Patients with any of the following abnormal laboratory parameters at the time of enrollment: AST and/or ALT > 3 times the upper limit of the reference range; creatinine clearance rate 265 µmol/L (> 3.0 mg/dL); platelets 5 times the upper limit of the reference range; 6. Pregnant, planning to become pregnant, or breastfeeding; 7. Suffer from severe infection, tumors, severe organ or system diseases, with an expected lifespan of = 3 months; 8. Unable to complete the study due to mental disorders, severe cognitive impairments, or other diseases; 9. Have relative or absolute contraindications for magnetic resonance imaging (such as metal in the body, claustrophobia, contrast agent allergy, severe kidney damage, epilepsy, hypotension, asthma, and other allergic respiratory diseases, and those with allergic tendencies); 10. Currently participating in other clinical studies or have participated in other clinical studies within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression of infarct volume;Improvement of upper limb function;Early improvement of neurological function; | — |
Secondary
| Measure | Time frame |
|---|---|
| Final infarction volume;The FMA and ARAT scores at the 90th and 180th days after randomizationThe FMA and ARAT scores at the 90th and 180th days after randomization;The 14th NIHSS score after randomization;The mRS scores and Barthel Index at the 90th and 180th days after randomization; | — |
Countries
China
Contacts
Public ContactJian Xia
Xiangya Hospital, Central South University
Outcome results
None listed