Pupil-Indexed Noninvasive Neuromodulation

Official title

Transcutaneous Auricular Vagus Nerve Stimulation: Motor Learning & Mechanisms

Overview

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.

Interventions

• 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.

Primary outcome measures

• Force Control Change [Time frame: Pre, 1-week Post, 1-month Post]

Eligibility criteria

Inclusion criteria

ALL PROSPECTIVE SUBJECTS:

• 18-75 years of age

PROSPECTIVE SUBJECTS DIAGNOSED WITH STROKE:

• Diagnosis of a single stroke resulting in hand impairment
• Diagnosis of stroke at least six months prior to the time of participation

Exclusion criteria

ALL PROSPECTIVE SUBJECTS:

• History of vestibular disorders or dizziness
• Difficulty maintaining alertness and/or remaining still
• Pregnant or expecting to become pregnant
• Diagnosis of neurological and/or musculoskeletal disorder(s) (other than stroke) that affect movement
• Ocular disease and/or impairment in more than one eye
• History of seizure and/or epilepsy
• Implants, devices, or foreign objects in the brain/body that are incompatible with MRI
• Body size that is incompatible with MRI scanner dimensions
• Anyone already enrolled and actively participating in another greater than minimal risk study.

PROSPECTIVE SUBJECTS DIAGNOSED WITH STROKE:

• Other impairments secondary to stroke (e.g., attention, cognition, etc.) that would interfere with the ability to understand study goals or follow simple instructions, as judged by the investigators.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh

Identifiers

NCT: NCT06282406 · N4532-R · I0X1RX004532

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗