Vagus nerve stimulation timing for arm recovery after stroke

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had a first ischemic stroke 3-36 months ago and still have moderate-to-severe arm weakness on one side. It tests vagus nerve stimulation for arm recovery.

Age

30 Years to 75 Years

Sex

All sexes can join.

Disease stage

First-time ischemic stroke on one side, in the middle cerebral artery area, sparing the diencephalon and basal ganglia, 3-36 months before surgery. Lasting moderate-to-severe arm weakness (FM-UE score of ≤42), with enough arm movement to take part in rehabilitation (score of ≥1 on the FM-UE elbow or finger items).

Main reasons for not taking part

• Excessive spasticity or contracture of the arm muscles (Modified Ashworth Scale = 4)
• Severe cognitive impairment (Mini Mental State Examination < 24)

The registry criteria, word for word

Check if you might fit

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?YesNo

What the trial wants to find out

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.

The 3 groups in the trial

• VNS activated in late stageTreatment being tested

  Following enrollment, participants with a history of stroke greater than 6 months 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.

  Treatment: Vagus Nerve Stimulation in late stage

• VNS activated in early stageExisting treatment, for comparison

  Following enrollment, participants with a history of stroke within 6 months 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.

  Treatment: Vagus Nerve Stimulation in early stage

• VNS not activated in early stageTreatment being tested

  Following enrollment, participants with a history of stroke within 6 months 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.When the a history of stroke was exceeded over 6 months, VNS was activated.

  Treatment: Vagus Nerve Stimulation in late stage