Safety and Efficacy Study of Implantable Neuromodulation for Poststroke Hemiplegia

Launched by CHINESE PLA GENERAL HOSPITAL · Nov 2, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two types of treatments—deep brain stimulation (DBS) and vagus nerve stimulation (VNS)—to see which one works better for improving movement in people who have hemiplegia, a condition where one side of the body is paralyzed after a stroke. The goal is to find out which treatment is safer and more effective, helping doctors and patients make informed choices about recovery options after a stroke.

To be eligible for this study, participants need to be between 18 and 80 years old and have experienced a specific type of stroke within the past 6 months to a year. They should have some motor difficulties on one side of their body and not have other serious health issues that could complicate the study. Throughout the trial, participants will undergo follow-ups at different times to track their progress, and they will have the chance to try both treatments under careful supervision. It’s important for potential participants to be willing to cooperate and sign consent forms to join the study. This trial is not yet recruiting participants, but it aims to provide valuable insights into treatment options for stroke recovery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Meet WHO or international diagnostic criteria for stroke disease;
• • 2. 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.
• • 3. Diagnosed by professional physicians combined with brain CT or magnetic resonance imaging and other imaging techniques;
• • 4. Between the ages of 18 and 80, male or female
• • 5. The responsible lesion in the unilateral white matter area indicated by cranial CT or MRI
• • 6. Relevant sequelae such as limb dysfunction after stroke, accompanied by unilateral limb motor dysfunction, proved to be right-handed by standardized examination.
• • 7. 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.
• • 8. Perfect clinical data
• • 9. Stable medical and physical condition with adequate nursing support and appropriate medical care in the patient's home community.
• • 10. The patient himself or voluntarily signs the informed consent and is willing to cooperate with relevant treatmen
• Exclusion Criteria:
• • 1. 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.
• • 2. Motor and sensory disturbances are not induced by stroke, nor by previous ischemic stroke, but stroke induced by trauma, brain tumor, etc.
• • 3. Serious comorbidities, such as malignant tumors, primary heart, liver, kidney or hematopoietic system diseases.
• • 4. History of cognitive impairment, mental disorder, drug abuse, drug allergy, and alcoholism.
• • 5. Infection or rupture of the skin on the forearm or leg.
• • 6. 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.).
• • 7. Pregnant or breast-feeding or have a recent birth plan.
• • 8. IS CLASSROUS.
• • 9. Congenital or acquired abnormalities of lower extremities (affecting joints and bones).
• • 10. Registration of investigators, their family members, employees, and other dependents.
• • 11. Severe joint contractures cause loss or limitation of lower limb activities.
• • 12. Blood system diseases with increased risk of bleeding during surgical intervention.
• • 13. Participate in another study drug study within 30 days before and during this study.
• • 14. Unable to complete the basic process, or difficult to maintain compliance and follow-up