Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
33 participants
INTERVENTIONAL
2018-03-20
2021-06-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Anxiety in PD
NCT05950347
Combining VNS With PT Interventions for Individuals With PD
NCT05871151
The Effect and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation on Gait Impairments in PD
NCT05561348
Neuroprotective Effects of Long-term TaVNS in Early Parkinson's Disease Patients
NCT06665113
Effect of taVNS of Brainstem Activation in Early and Late Parkinson's Disease Patients - an fMRI Study
NCT05967598
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active taVNS
Active taVNS
Patients will be masked to transcutaneous stimulation of the auricular branch of the vagus nerve at the tragus
Sham Stimulation
Sham Stimulation
Sham stimulation involves identical perceptual threshold finding and stimulation parameters as active stimulation, with the exception of stimulation target. Sham stimulation will be delivered to the left earlobe, a target believed to have little to no vagal nerve innervation.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Active taVNS
Patients will be masked to transcutaneous stimulation of the auricular branch of the vagus nerve at the tragus
Sham Stimulation
Sham stimulation involves identical perceptual threshold finding and stimulation parameters as active stimulation, with the exception of stimulation target. Sham stimulation will be delivered to the left earlobe, a target believed to have little to no vagal nerve innervation.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Idiopathic Parkinson's Disease Diagnosis
* Disease Stage: Hoehn and Yahr stage 2-3
* Patient requires a minimum of 3 doses of levodopa daily
* Willingness to be videotaped
Exclusion Criteria
* Parkinson's Disease psychosis
* Ear trauma
* Facial pain
* Traumatic Brain Injury or clinical history of stroke
* Metal implants above the shoulders
* History of myocardial infarction or arrhythmia, bradycardia
* Active respiratory disorder
* Alcohol or substance use disorders
* History of Deep Brain Stimulation (DBS) or other brain surgery
* Epilepsy
* Pregnancy
* B-Blockers, dopamine blocking agent, antiarrhythmic medication, acetylcholine esterase inhibitor, midodrine, florinef, droxidopa, or anticholinergic drugs
40 Years
79 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of South Carolina
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Vanessa Hinson
Program Director
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vanessa Hinson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
00073767
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.