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Recruiting NCT06303960

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

Early Phase I Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bilateral Cerebellar deep brain stimulation, Unilateral Cerebellar deep brain stimulation, Vagus Nerve Stimulation.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 30 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Comparison of Treatment Results Between Cerebellar DBS and Vagus Stimulation for Post-stroke Motor Rehabilitation: a Randomized Clinical Trial

Overview

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.

Interventions

  • Device Bilateral Cerebellar deep brain stimulation
    Participants underwent stereotactic implantation of a single DBS lead in the area of the cerebellar DN contralateral to the lesioned cerebral hemisphere using a frame-based technique similar to that used in DBS for movement disorders. All participants received an 4-channel lead (Medtronic,3389）with electrode arrays up to 15.5 mm in length. Then bilateral stimulation was activated after 1 month post-DBS
  • Device Unilateral Cerebellar deep brain stimulation
    Participants underwent stereotactic implantation of a single DBS lead in the area of the cerebellar DN contralateral to the lesioned cerebral hemisphere using a frame-based technique similar to that used in DBS for movement disorders. All participants received an 4-channel lead (Medtronic,3389）with electrode arrays up to 15.5 mm in length. Then unilateral stimulation was activated after 1 month post-DBS
  • Device Vagus Nerve Stimulation
    Device implantation was done under general anaesthesia. A horizontal neck crease incision was created left of the midline at the level of the cricoid cartilage. After the vagus nerve was identified, the stimulation lead was wrapped around the vagus nerve. The lead was then tunnelled subcutaneously to the pulse generator device which was contained in a subcutaneous pocket in the pectoral region.

Primary outcome measures

  • FM-UE scores between cerebellar DBS and VNS [Time frame: 12 months after device implantation]
Secondary outcome measures (8)
  • Arm Motor Ability Test (AMAT) between cerebellar DBS and VNS [Time frame: 12 months after device implantation]
  • the Nine-Hole Peg Test between cerebellar DBS and VNS [Time frame: 12 months after device implantation]
  • the Bilateral Box and Block Test between cerebellar DBS and VNS [Time frame: 12 months after device implantation]
  • Short Form Health Survey (SF-12) between cerebellar DBS and VNS [Time frame: 12 months after device implantation]
  • the EuroQol Five Dimensions Questionnaire (EQ-5D) between cerebellar DBS and VNS [Time frame: 12 months after device implantation]
  • the Beck Depression Inventory or the Beck Anxiety Inventory between cerebellar DBS and VNS [Time frame: 12 months after device implantation]
  • nerve conduction velocity between cerebellar DBS and VNS [Time frame: 12 months after device implantation]
  • safety and feasibility of VNS and cerebellar DBS [Time frame: 12 months after device implantation]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Chao Zhang — Jinan

Identifiers

NCT: NCT06303960 · VNS or DBS for stroke

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗