Brain Stimulation Compared With Vagus Nerve Stimulation for Arm Recovery After Stroke
Tests cerebellar deep brain stimulation and vagus nerve stimulation in people with chronic stroke.
Plain-language title generated from the registry record
Registry title: Cerebellar Deep Brain Stimulation or VNS for Chronic Post-stroke Motor Rehabilitation
Key facts
- Where
- Jinan, ChinaSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 75 years old?
Source: NCT06303960, who can take part
Where in China
- Chao ZhangJinan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Qilu Hospital of Shandong University
- Trial code
- NCT06303960
- Record updated
- 17 April 2025
- Original description
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.Read full original descriptionShow less
The Comparison of Treatment Results Between Cerebellar DBS and Vagus Stimulation for Post-stroke Motor Rehabilitation: a Randomized Clinical Trial
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.
Inclusion: 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: Severe cognitive impairment (Mini Mental State Examination < 24); Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4).