Brain Stimulation Compared With Vagus Nerve Stimulation 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 12-36 months before surgery and still have moderate-to-severe weakness in one arm. They must be able to move the arm a little to take part in rehabilitation.

Age

30 Years to 75 Years

Sex

All sexes can join.

Disease stage

A first-time, one-sided ischemic stroke in the middle cerebral artery area that spared the diencephalon and basal ganglia, 12-36 months before surgery. Lasting moderate-to-severe upper-arm weakness (FM-UE score of ≤42).

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)
• Not enough arm movement for rehabilitation (FM-UE score under 1 on elbow flexion, elbow extension or finger mass flexion or extension)

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 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.

The 3 groups in the trial

• Bilateral Cerebellar deep brain stimulationExisting treatment, for comparison

  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.

• Unilateral Cerebellar deep brain stimulationExisting treatment, for comparison

  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.

• Vagus Nerve StimulationTreatment being tested

  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.