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Transcutaneous Auricular Vagus Nerve Stimulation to Enhance Motor Learning

Primary Purpose

Neurological Injury, Motor Disorders, Paresis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Vagus Nerve Stimulation
Sponsored by
VA Pittsburgh Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Neurological Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

(For prospective subjects diagnosed with stroke)

  • Confirmed diagnosis of a single stroke at least six months prior to participation

Exclusion Criteria:

  • History of vestibular disorders or dizziness
  • Diagnosis of neurological disorders affecting movement
  • Ocular disease and/or impairment in more than one eye
  • Pregnant or expecting to become pregnant
  • Difficulty maintaining alertness and/or remaining still

Sites / Locations

  • Human Engineering Research LaboratoriesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Transcutaneous Vagus Nerve Stimulation

Transcutaneous Stimulation (Sham)

Arm Description

Transcutaneous vagus nerve stimulation paired with visuomotor task training

Transcutaneous stimulation paired with visuomotor task training

Outcomes

Primary Outcome Measures

Precision grip stability (coefficient of variation or root-mean-square error)
The ability to stabilize precision grip according to target force and/or preload force will be quantified by calculating coefficient of variation (CV) or root-mean-square error (RMSE) which characterize variability in relation to mean force or target force.

Secondary Outcome Measures

Force signal composition (Fourier transform)
The force signal oscillates at various frequencies and will be decomposed with a Fourier transform to quantify the relative contribution of higher frequencies.

Full Information

First Posted
March 16, 2022
Last Updated
April 14, 2023
Sponsor
VA Pittsburgh Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT05316519
Brief Title
Transcutaneous Auricular Vagus Nerve Stimulation to Enhance Motor Learning
Official Title
Transcutaneous Auricular Vagus Nerve Stimulation: Mechanisms and Therapeutic Potential
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Pittsburgh Healthcare System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Vagus nerve stimulation (VNS) activates neural pathways leading to the release of chemicals that 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 activates neural pathways implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms that are modulated by auricular stimulation and its potential to enhance motor learning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurological Injury, Motor Disorders, Paresis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Sham-controlled
Masking
Participant
Masking Description
Single-blind
Allocation
Randomized
Enrollment
4 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous Vagus Nerve Stimulation
Arm Type
Experimental
Arm Description
Transcutaneous vagus nerve stimulation paired with visuomotor task training
Arm Title
Transcutaneous Stimulation (Sham)
Arm Type
Placebo Comparator
Arm Description
Transcutaneous stimulation paired with visuomotor task training
Intervention Type
Other
Intervention Name(s)
Transcutaneous Vagus Nerve Stimulation
Intervention Description
Visuomotor task training with transcutaneous stimulation targeting landmark that activates biomarker
Primary Outcome Measure Information:
Title
Precision grip stability (coefficient of variation or root-mean-square error)
Description
The ability to stabilize precision grip according to target force and/or preload force will be quantified by calculating coefficient of variation (CV) or root-mean-square error (RMSE) which characterize variability in relation to mean force or target force.
Time Frame
1 month post training
Secondary Outcome Measure Information:
Title
Force signal composition (Fourier transform)
Description
The force signal oscillates at various frequencies and will be decomposed with a Fourier transform to quantify the relative contribution of higher frequencies.
Time Frame
1 month post training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: (For prospective subjects diagnosed with stroke) Confirmed diagnosis of a single stroke at least six months prior to participation Exclusion Criteria: History of vestibular disorders or dizziness Diagnosis of neurological disorders affecting movement Ocular disease and/or impairment in more than one eye Pregnant or expecting to become pregnant Difficulty maintaining alertness and/or remaining still
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas Gatto
Phone
412-822-3700
Email
Nicholas.Gatto@va.gov
Facility Information:
Facility Name
Human Engineering Research Laboratories
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Gatto
Phone
412-822-3700
Email
Nicholas.Gatto@va.gov

12. IPD Sharing Statement

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Transcutaneous Auricular Vagus Nerve Stimulation to Enhance Motor Learning

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