NCT07226284

Effects of Vagal Nerve Stimulation on Leg Muscle Activity and Posture in Parkinson's Disease

The Effects of Vagus Nerve Stimulation on Intrinsic Lower Leg Spinal Motoneuron Excitability in Parkinson's Disease.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 21 Years – 76 Years
• Healthy volunteers: Accepted

Summary

This study is designed to better understand the mechanisms contributing to impaired activation of leg muscles in people with Parkinson's disease (PD) and to test if stimulation of a nerve at the neck can improve muscle activation, walking and balance.

Detailed description

The goals of this project are twofold: (i) to test the hypothesis that persistent inward currents (PICs) in spinal motoneurons of the ankle extensors are reduced in people with Parkinson's disease and that these changes are associated with impaired postural control and (ii) to examine the acute effects of non-invasive vagus nerve stimulation (nVNS) on PICs and postural control. This project will conduct experiments to test the hypothesis that the firing properties of muscles that control the ankle are significantly altered in people with PD compared to matched healthy adults and that these changes in activity are related to the severity of postural control deficits. In addition, this project will examine the acute effects of non-invasive vagal nerve stimulation (nVNS), an intervention that increases activity in the locus coeruleus and raphe nucleus, on the firing properties of ankle muscles and postural control. If successful, this work will be the first to demonstrate that brainstem pathways that control muscle firing properties are altered in people with PD and are associated with postural impairment. The preliminary trial of nVNS will provide evidence that postural muscle activity can be improved with stimulation and improve postural control. These findings will provide critical preliminary data required to move forward with a clinical trial of nVNS in PD.

Conditions

• PARKINSON DISEASE (Disorder)
• Parkinson's Disease (PD)

Interventions

Type	Name	Description
DEVICE	Vagal nerve stimulation	The gammaCore non-invasive vagus nerve stimulator (nVNS) is a hand-held portable device that is used to apply electrical stimulation to the vagus nerve via two electrodes.
OTHER	No intervention	No nVNS is applied in the baseline experiment. Sham nVNS is applied for experiment two

Timeline

• Start date: 2026-02-10
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2025-11-10
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study