Ischemic stroke
Conditions
Interventions
Single target stimulation group:Single-target rTMS (peripheral sham stimulus) + multisensory stimulation technology
rTMS stimulation protocol: the primary motor cortex of the affected cerebral hemisph
Multi-target stimulation group:Multi-target area loop modulation + multi-sensory stimulation technology
Multi-targeted rTMS loop modulation protocol: Central stimulation: M1 area of the affected corte
peripheral stimulation: circular coil
stimulation site: brachial plexus (center of the coil is placed on the medial side of the angle formed by the clavicle and the humerus)
intensity: gradually increase the intensity until observable activity occurs in the upper limb. The intensity was 80%-120% (adjusted according to the patients
Sponsors
Department of Rehabilitation, Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Unilateral hemispheric ischemic stroke with first onset and no more than 14 days from onset at enrollment; (2) Age >= 18 years and <= 80 years, regardless of gender; (3) Vital signs are stable, can actively move paralyzed limbs, modified Rankin Scale (mRS) <= 2, upper limb Brunnstrom stage I-IV, and Fugl-Meyer Upper Extremity Evaluation Exercise Scale (FMA-UE) <= 54 points; (4) A sense of autonomy and independence, understanding, agreeing to participate in this study and signing the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Past experience with rehabilitation therapy such as neuromodulation, neurodevelopmental therapy, or other clinical studies; (2) Presence of any medical condition that may be aggravated or result in adverse effects from participation in the trial (including, but not limited to, uncontrolled hypertension, psychiatric disorders, tumors, epilepsy, bone fractures, etc.); (3) Presence of sensory dysfunction with reference to the upper extremity portion of the Fugl-Meyer Sensory Assessment Subscale (FMA-S) score; (4) The presence of other diseases that affect motor function in the past, such as traumatic brain injury, Parkinson's syndrome, etc; (5) Patients with contraindications to magnetic resonance examination, such as implantation of metallic/non-metallic implants (including but not limited to pacemakers, cochlear implants, metallic foreign bodies, etc.), febrile convulsions, claustrophobia, and critically ill patients requiring life support and resuscitation; (6) Presence of moderate to severe cognitive impairment with a Montreal Cognitive Assessment (MOCA) score <18; (7) Presence of lesions on the scalp, cranial defects, or craniectomy; (8) Pregnant or breastfeeding women or patients with recent plans to prepare for pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Upper Extremity Section of the Fugl-Meyer Assessment Scale ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Barthel Index;Muscle strength and tension;Electroencephalography (EEG);Magnetoencephalography (MEG);Multi-model Magnetic Resonance Imaging;Neurophysiology test; | — |
Countries
China
Contacts
Public ContactXu Dongsheng
Department of Rehabilitation, Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai University of Traditional Chinese MedicineTraditional Chinese Medicine
Outcome results
None listed