Clinical trial NCT06303960: Cerebellar Deep Brain Stimulation or VNS for Chronic Post-stroke Motor Rehabilitation
Official title: The Comparison of Treatment Results Between Cerebellar DBS and Vagus Stimulation for Post-stroke Motor Rehabilitation: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Stroke
Keywords: Hemiparesis
Cerebellar Deep Brain Stimulation
VNS
Limb Motor Function Rehabilitation
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: FM-UE scores between cerebellar DBS and VNS
timeFrame: 12 months after device implantation
Secondary outcomes:
measure: Arm Motor Ability Test (AMAT) between cerebellar DBS and VNS
timeFrame: 12 months after device implantation
measure: the Nine-Hole Peg Test between cerebellar DBS and VNS
timeFrame: 12 months after device implantation
measure: the Bilateral Box and Block Test between cerebellar DBS and VNS
timeFrame: 12 months after device implantation
measure: Short Form Health Survey (SF-12) between cerebellar DBS and VNS
timeFrame: 12 months after device implantation
measure: the EuroQol Five Dimensions Questionnaire (EQ-5D) between cerebellar DBS and VNS
timeFrame: 12 months after device implantation
measure: the Beck Depression Inventory or the Beck Anxiety Inventory between cerebellar DBS and VNS
timeFrame: 12 months after device implantation
measure: nerve conduction velocity between cerebellar DBS and VNS
timeFrame: 12 months after device implantation
measure: safety and feasibility of VNS and cerebellar DBS
timeFrame: 12 months after device implantation
Other outcomes:
Locations:
city: Jinan
country: China
facility: Chao Zhang
state: Sichuan
Study officials:
References: