Cerebellar Deep Brain Stimulation or VNS for Chronic Post-stroke Motor Rehabilitation

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Mar 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called deep brain stimulation to help people who have difficulty using their arms after a stroke. The researchers want to see if stimulating both sides of a part of the brain called the cerebellum is more effective than stimulating just one side. This trial is for people who had their first stroke in a specific area of the brain 12 to 36 months ago and still have moderate to severe weakness in their arm. To participate, individuals need to have some ability to move their arm, but they should not have severe muscle tightness or significant thinking problems.

Participants in this study will receive either bilateral (both sides) or unilateral (one side) stimulation and will be closely monitored to see how it affects their ability to move their arm. The trial is currently recruiting people of all genders between the ages of 18 and 80. This research could help improve rehabilitation strategies for stroke survivors, potentially leading to better outcomes in regaining arm function.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Eligible individuals suffered a first-time, unilateral, ischemic stroke in the middle cerebral artery territory that spared the diencephalon and basal ganglia 12-36 months before surgery.
• • Individuals with persistent moderate-to-severe upper-extremity hemiparesis as defined by an FM-UE score of ≤42
• • Sufficient upper-extremity motor ability to engage in rehabilitation (that is, a score of ≥1 on the FM-UE elbow flexion, elbow extension or finger mass flexion or extension).
• Exclusion Criteria:
• • Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4)
• • Severe cognitive impairment (Mini Mental State Examination \< 24)