Motor Rehabilitation, Stroke
Conditions
Keywords
Hemiparesis, VNS, Limb Motor Function Rehabilitation
Brief summary
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.
Interventions
DEVICEVagus Nerve Stimulation in early stage
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.
DEVICEVagus Nerve Stimulation in late stage
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
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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).
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FM-UE scores between early and late 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
| Measure | Time frame | Description |
|---|---|---|
| Arm Motor Ability Test (AMAT) between early and late 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 early and late 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 early and late 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 early and late 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 early and late 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. |
| safety and feasibility of early and late VNS | 12 months after device implantation | The incidence of adverse events including hemorrhages, infections, deaths or major perioperative complications during the study |
Countries
China
Contacts
Primary ContactChao Zhang
Outcome results
None listed