Safety and Efficacy Study of Implantable Neuromodulation for Poststroke Hemiplegia

Korábbi kezelés

• Motor and sensory disturbances are not induced by stroke, nor by previous ischemic stroke, but stroke induced by trauma, brain tumor, etc.
• Possess a pacemaker, metal stent, plate, or implant susceptible to electrical impulses in the body (pacemaker or defibrillator, baclofen pump, deep brain stimulator, Ventricular shunts, shrapnel, etc.).
• Participate in another study drug study within 30 days before and during this study.

Más betegség

• Glasgow Coma Scale (GSC) score below 15, Minimum Mental State Examination (MMSE) assessment for dementia indicated, suffering from mental disturbance and unable to cooperate with examination or treatment.
• Serious comorbidities, such as malignant tumors, primary heart, liver, kidney or hematopoietic system diseases.
• History of cognitive impairment, mental disorder, drug abuse, drug allergy, and alcoholism.
• Infection or rupture of the skin on the forearm or leg.
• Blood system diseases with increased risk of bleeding during surgical intervention.

Egyéb

• Pregnant or breast-feeding or have a recent birth plan.
• IS CLASSROUS.
• Congenital or acquired abnormalities of lower extremities (affecting joints and bones).
• Registration of investigators, their family members, employees, and other dependents.
• Severe joint contractures cause loss or limitation of lower limb activities.
• Unable to complete the basic process, or difficult to maintain compliance and follow-up

• Meet WHO or international diagnostic criteria for stroke disease;
• The first unilateral supratentorial ischemic or hemorrhagic stroke, the condition is stable after acute treatment of ischemic stroke, the course of disease is 6 months ≤ 1 year, and participate in 2 evaluations (screening and baseline) before enrollment.
• Diagnosed by professional physicians combined with brain CT or magnetic resonance imaging and other imaging techniques;
• Between the ages of 18 and 80, male or female
• The responsible lesion in the unilateral white matter area indicated by cranial CT or MRI
• Relevant sequelae such as limb dysfunction after stroke, accompanied by unilateral limb motor dysfunction, proved to be right-handed by standardized examination.
• National Institutes of Health Stroke Scale (NIHSS) score from 2 to 20, grades paralyzed muscle strength, between grades 1 and 4, WISCI II, grade >2 (0-20 items): Assisted by one or more persons, able to walk at least 10 m, and less responsive to conventional rehabilitation prior to inclusion.
• Perfect clinical data
• Stable medical and physical condition with adequate nursing support and appropriate medical care in the patient's home community.
• The patient himself or voluntarily signs the informed consent and is willing to cooperate with relevant treatmen