Paresis Clinical Trial - Pupil-Indexed Noninvasive Neuromodulation

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Existing evidence supports the use of VNS to enhance the effects of traditional therapy on impairments due to neurological injury (Dawson et al., 2021). 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 (Follesa et al., 2007; Roosevelt et al., 2006). It is also known that the auricular branch of the vagus nerve innervates portions of the external ear (Safi et al., 2016; Butt et al., 2020) 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 (Urbin et al., 2021), 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. ;

Study Design

Related Conditions & MeSH terms

Paresis

Clinical Trial Details

NCT number	NCT06282406
Study type	Interventional
Source	VA Office of Research and Development
Contact	Michael A Urbin, PhD
Phone	(412) 688-6000
Email	Michael.Urbin@va.gov
Status	Not yet recruiting
Phase	N/A
Start date	June 3, 2024
Completion date	August 5, 2028

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