NCT06282406

Pupil-Indexed Noninvasive Neuromodulation

Transcutaneous Auricular Vagus Nerve Stimulation: Motor Learning & Mechanisms

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Vagus nerve stimulation (VNS) is thought to activate neural pathways that release chemicals which promote plasticity and learning. Previous work has shown that the auricular branch of the vagus nerve innervates landmarks on the external ear. Work from the PI's laboratory has shown that electrical current applied to the external ear modulates physiological indexes of brain states implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms modulated by auricular stimulation to support possible therapeutic effects in the form of motor learning.

Detailed description

Existing evidence supports the use of VNS to enhance the effects of traditional therapy on impairments due to neurological injury. It is known that the vagus nerve forms contacts with neuromodulatory nuclei in the brainstem that release of chemicals shown to be critically involved in attentional control and memory formation. It is also known that the auricular branch of the vagus nerve innervates portions of the external ear providing a possible means to engage similar neural pathways noninvasively via transcutaneous auricular vagus nerve stimulation (taVNS). Recent work from the PI's laboratory shows that electrical current applied to landmarks on the external ear elicits transient effects on pupil dilation, an established physiological index of brain states that support learning. Given the ability to engage the biomarker, the investigators aim to further investigate physiological mechanisms modulated by taVNS and possible effects on learning.

Conditions

• Paresis

Interventions

Type	Name	Description
OTHER	Transcutaneous Electrical Stimulation	Electrical pulse trains applied to the skin overlying putative sites of auricular vagal innervation.
OTHER	Sham	Electrodes placed on the skin overlying putative sites of auricular vagal innervation but no current administered.

Timeline

• Start date: 2024-06-03
• Primary completion: 2028-04-03
• Completion: 2028-08-05
• First posted: 2024-02-28
• Last updated: 2025-06-24

Locations

1 site across 1 country: United States