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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
China
Chao Zhang
RECRUITING
Jinan
Time Frame
Start Date: 2024-03-15
Estimated Completion Date: 2026-03-07
Participants
Target number of participants: 100
Treatments
Active_comparator: 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.
Active_comparator: 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.
Experimental: Vagus Nerve 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 VNS system. 1 months later, VNS was activated unilaterally.
Sponsors
Leads: Qilu Hospital of Shandong University

This content was sourced from clinicaltrials.gov