The Comparison of Treatment Results Between Cerebellar DBS and Vagus Stimulation for Post-stroke Motor Rehabilitation: a Randomized Clinical Trial
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Qilu Hospital of Shandong University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- FM-UE scores between cerebellar DBS and VNS
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts.In this open-label, randomized phase I trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with bilateral or unilateral stimulation. Vagus nerve stimulation was also conducted for motor function after ischaemic Stroke.We hypothesized that cerebellar stimulation was superior to vagus stimulation as the motor rehabilitation after stroke benefits from both side of cerebellum.
Investigators
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)
Outcomes
Primary Outcomes
FM-UE scores between cerebellar DBS and VNS
Time Frame: 12 months after device implantation
The outcomes includes each participant's Fugl-Meyer assessment scale (FM-UE) scores for each monthly visit. FM-UE scores range from 0 to 100 and the higher scores indicated better outcome of movement.
Secondary Outcomes
- Arm Motor Ability Test (AMAT) between cerebellar DBS and VNS(12 months after device implantation)
- the Nine-Hole Peg Test between cerebellar DBS and VNS(12 months after device implantation)
- the Bilateral Box and Block Test between cerebellar DBS and VNS(12 months after device implantation)
- Short Form Health Survey (SF-12) between cerebellar DBS and VNS(12 months after device implantation)
- the EuroQol Five Dimensions Questionnaire (EQ-5D) between cerebellar DBS and VNS(12 months after device implantation)
- the Beck Depression Inventory or the Beck Anxiety Inventory between cerebellar DBS and VNS(12 months after device implantation)
- nerve conduction velocity between cerebellar DBS and VNS(12 months after device implantation)
- safety and feasibility of VNS and cerebellar DBS(12 months after device implantation)