Paired Vagus Nerve Stimulation (VNS) With Rehabilitation for Upper Limb Function Improvement After Stroke

MicroTransponder

Status: Completed

Conditions: Stroke

Treatments: Device: Vivistim System; Other: Rehab Only

Study type: Interventional

Funder types: Industry

Identifiers

NCT01669161

Mt-St-01

Details and patient eligibility

About

Patients (UK only) at least 6 months post stroke, with upper limb deficits, may enroll. Patients will be randomized to one of two groups - a group implanted with a device that allows pairing VNS with rehabilitation and a group that only receives rehabilitation (no implant). Patients have two baseline evaluations, one evaluation after implant but before initiation of treatment, and then six weeks of rehabilitation or rehabilitation + VNS, followed by post acute therapy evaluations at 1, 7, and 30 days after the 6-weeks of treatment. The intent is to assess safety and provide preliminary effectiveness information for VNS for upper limb functional improvement after stroke. Implanted patients may receive longer-term treatment and follow-up after the acute study.

Enrollment: 21 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Major Inclusion Criteria:

1. History of unilateral supratentorial ischemic stroke that occurred at least 6 months prior
2. Age > 18 years and < 80 years
3. Right or left sided weakness of upper extremity

Major Exclusion Criteria:

1. Hemorrhagic stroke
2. Any deficits in language or attention that interferes with reasonable study participation
3. Presence of significant apraxia
4. Profound Sensory loss
5. Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including alcohol or drug abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

21 participants in 2 patient groups

VNS

Experimental group

Description:

VNS (vagus nerve stimulation) paired with rehabilitation as provided by the Vivistim System.

Treatment:

Device: Vivistim System

Rehab Only

Active Comparator group

Description:

Rehabilitation only (no implant, no VNS)

Treatment:

Other: Rehab Only