Status:
NOT_YET_RECRUITING
Safety and Efficacy Study of Implantable Neuromodulation for Poststroke Hemiplegia
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Stroke Sequelae
Deep Brain Stimulation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Background: Hemiplegia is a common complication after a stroke. Studies have shown that traditional medical and rehabilitation treatments are not good for improving patients' motor function, deep brai...
Detailed Description
The incidence of stroke has been more than 20 million stroke patients worldwide, and it has become the third highest-burden disease in the world. The disability rate of stroke is as high as 60-80%. Th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- Motor and sensory disturbances are not induced by stroke, nor by previous ischemic stroke, but stroke induced by trauma, brain tumor, etc.
- 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.
- 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.).
- 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.
- Blood system diseases with increased risk of bleeding during surgical intervention.
- Participate in another study drug study within 30 days before and during this study.
- Unable to complete the basic process, or difficult to maintain compliance and follow-up
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2030
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT06121947
Start Date
November 10 2023
End Date
October 30 2030
Last Update
November 8 2023
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, China