Wether VNS in Early Stage (3 Months) is Safe and More Beneficial for Post-stroke Motor Rehabilitation

ConditionsStroke Motor Rehabilitation

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age30-75

SponsorQilu Hospital of Shandong University

About this trial

Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts. In previous study, Vagus nerve stimulation was constricted to patients 9 months after stroke. In this randomized phase I trial, we would apply vagus nerve stimulation in an early stage (\<6 month) and observe its theraputic effect on motor function after ischaemic Stroke.We hypothesized that the early stimulation could be safe and more beneficial compared to stimulation in late stage.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eligible individuals suffered a first-time, unilateral, ischemic stroke in the middle cerebral artery territory that spared the diencephalon and basal ganglia 3-36 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).

Disqualifiers

Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4) . Severe cognitive impairment (Mini Mental State Examination < 24)

Trial design

Design model

Parallel

Treatments tested in this trial

Vagus Nerve Stimulation in early stage
Device
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.
Vagus Nerve Stimulation in late stage
Device
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

Treatment groups

100 Participants

are divided into 3 treatment groups

Group A: VNS activated in late stageExperimental treatment 1 intervention

Group B: VNS activated in early stageActive comparator 1 intervention

Group C: VNS not activated in early stageExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

FM-UE scores between early and late VNS

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.

Time frame