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

Early Phase 1

Recruiting

• Conditions: Stroke
• Interventions: Device: Bilateral Cerebellar deep brain stimulation; Device: Unilateral Cerebellar deep brain stimulation

• Registration Number: NCT06303960
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-03-04
• Study First Posted: 2024-03-12
• Study Start: 2024-03-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-06-07
• Study Completion: 2026-03-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilateral Cerebellar deep brain stimulation	Bilateral Cerebellar deep brain stimulation	Following enrollment, participants underwent 1 month of upper-extremity rehabilitation twice per week to rule out potential for recovery with rehabilitation therapy alone. Thereafter, each participant underwent surgical implantation of the DBS system, with the lead implanted in the DN contralateral to the stroke-affected cerebral hemisphere. 1 months later, DBS was activated bilaterally.
Unilateral Cerebellar deep brain stimulation	Unilateral Cerebellar deep brain stimulation	Following enrollment, participants underwent 1 month of upper-extremity rehabilitation twice per week to rule out potential for recovery with rehabilitation therapy alone. Thereafter, each participant underwent surgical implantation of the DBS system, with the lead implanted in the DN contralateral to the stroke-affected cerebral hemisphere. 1 months later, DBS was activated unilaterally.

Primary Outcome Measures

Name	Time	Method
FM-UE scores between cerebellar DBS and VNS	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 Outcome Measures

Name	Time	Method
Arm Motor Ability Test (AMAT) between cerebellar DBS and VNS	12 months after device implantation	The outcomes includes each participant's the Arm Motor Ability Test (AMAT) for each monthly visit. AMAT scores range from 0 to 57 and the higher scores indicated better outcome of movement.
the Nine-Hole Peg Test between cerebellar DBS and VNS	12 months after device implantation	The outcomes includes each participant's the Nine-Hole Peg Test for each monthly visit.
the Bilateral Box and Block Test between cerebellar DBS and VNS	12 months after device implantation	The outcomes includes each participant's the Bilateral Box and Block Test for each monthly visit.
Short Form Health Survey (SF-12) between cerebellar DBS and VNS	12 months after device implantation	The outcomes includes each participant's score of Short Form Health Survey (SF-12) for each monthly visit. SF-12 scores range from 0 to 60 and the higher scores indicated better outcome of movement.
the EuroQol Five Dimensions Questionnaire (EQ-5D) between cerebellar DBS and VNS	12 months after device implantation	The outcomes includes each participant's score of the EuroQol (EQ-5D) scores range from 0 to 36 for each monthly visit.
the Beck Depression Inventory or the Beck Anxiety Inventory between cerebellar DBS and VNS	12 months after device implantation	The outcomes includes each participant's score of the Beck Depression Inventory or the Beck Anxiety Inventory for each monthly visit.
nerve conduction velocity between cerebellar DBS and VNS	12 months after device implantation	The outcomes includes each participant's nerve conduction velocity for each monthly visit recorded by flexible electrode.
safety and feasibility of VNS and cerebellar DBS	12 months after device implantation	The incidence of adverse events including hemorrhages, infections, deaths or major perioperative complications during the study

Trial Locations

Locations (1)

Chao Zhang; 🇨🇳 Jinan, Sichuan, China