Pupil-Indexed Noninvasive Neuromodulation

NCT06282406 | Recruiting

• 2 other identifiers: N4532-RI0X1RX004532
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Paresis

Keywords

Learning; Neurological Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Force Control Change

  Subjects will be tested on the same task used for training that involves controlling finger forces.

  Pre, 1-week Post, 1-month Post

Study Arms (5)

Paired, Sub-Threshold Stim

EXPERIMENTAL

Sub-threshold stimulation paired with successful task repetitions

Other: Transcutaneous Electrical Stimulation

Paired, Supra-Threshold Stim

EXPERIMENTAL

Supra-threshold stimulation paired with successful task repetition

Other: Transcutaneous Electrical Stimulation

Unpaired, Sub-Threshold Stim

EXPERIMENTAL

Sub-threshold stimulation after successful task repetition

Other: Transcutaneous Electrical Stimulation

Unpaired, Supra-Threshold Stim

EXPERIMENTAL

Supra-threshold stimulation after successful task repetition

Other: Transcutaneous Electrical Stimulation

Sham

SHAM COMPARATOR

No stimulation

Other: Sham

Interventions

Transcutaneous Electrical Stimulation OTHER

Electrical pulse trains applied to the skin overlying putative sites of auricular vagal innervation.

Paired, Sub-Threshold Stim; Paired, Supra-Threshold Stim; Unpaired, Sub-Threshold Stim; Unpaired, Supra-Threshold Stim

Sham OTHER

Electrodes placed on the skin overlying putative sites of auricular vagal innervation but no current administered.

Sham

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ALL PROSPECTIVE SUBJECTS:
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

RECRUITING

MeSH Terms

Conditions

Paresis

Interventions

Transcutaneous Electric Nerve Stimulation; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Michael A. Urbin, PhD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael A Urbin, PhD

CONTACT

(412) 688-6000; Michael.Urbin@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized into one of 5 groups and receive the designated stimulation/sham during a training protocol designed to facilitate motor learning.

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: June 3, 2024
• Primary Completion (Estimated): April 3, 2028
• Study Completion (Estimated): August 5, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)