MedTrace Logo

Combining VNS With PT Interventions for Individuals With PD

NCT05871151 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-12-17

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the combined effects of non-invasive neuromodulation (specifically transauricular Vagus Nerve Stimulation) with exercise interventions to improve physical function and quality of life in individuals with Parkinsons Disease.

Conditions

  • Parkinson Disease

Interventions

DEVICE

taVNS

Trans-auricular Vagus Nerve Stimulation is a non-invasive method of stimulating the auricular branch of the vagus nerve through the inner ear. Trans-auricular Vagus Nerve Stimulation will be provided using a commercially available device. The investigators will use custom earbuds that will make the experience significantly more comfortable than traditional transauricular Vagus Nerve Stimulation.

BEHAVIORAL

Exercise

All participants will be guided through exercises led by a trained exercise specialist, and will include: 1) intensive exercises that focus on increasing the size and amplitude of movements; 2) task-specific practice, which involves practicing functional tasks, such as dressing, bathing, and cooking, in order to transfer the gains made in therapy to real-life situations. The exercise intervention proposed involves the supervision of a licensed PT at all times during the treatment session. Exercise will be provided in a clinical setting, 45 minutes per session, up to 3 sessions/week, for 4-6 weeks total.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Alexandra Evancho, DPT · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-05-25
Completion
2024-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05871151 on ClinicalTrials.gov