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Purpose

The purpose of this study is to find out whether a type of gentle nerve stimulation, called transcutaneous auricular Vagus Nerve Stimulation (taVNS), can help improve how the body regulates heart rate and blood pressure in people with Parkinson's Disease (PD). Problems with heart rate and blood pressure control are common and can make it harder for people to exercise or do daily activities. By using this non-invasive form of nerve stimulation and testing how it affects the body's natural responses, this study hopes to learn if taVNS could be a helpful tool to support physical therapy and improve overall function.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of idiopathic PD - Stable medication for at least 4 weeks prior to the study

Exclusion Criteria

  • Use of beta blockers - Sustained severe hypertension (>/= 180/110 mmHg while seated) - Significant uncontrolled cardiac arrhythmia - Unstable angina - Congestive heart failure - History of myocardial infarction - History of seizures - Severe cognitive impairment - Pregnant women or women who are planning to become pregnant

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Other
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1 		Active taVNS on Visit 2, Sham taVNS on Visit 3. Active taVNS is delivered at 30 Hz, 250 µs, 0.1-4 mA for 15 minutes. Sham taVNS is delivered at 0 mA output for 15 minutes. A minimum washout period of 48 hours will be observed between visits.
  • Device: transcutaneous auricular vagus nerve stimulation
    Participants will sit quietly while receiving active nerve stimulation for 15 minutes. A gentle electrical current is delivered through hydrogel electrodes placed in the ear. The active stimulation parameters are set to 30 Hz, 250 µs, and 0.1-4 mA.
Experimental
Group 2 		Sham taVNS on Visit 2, Active taVNS on Visit 3. Active taVNS is delivered at 30 Hz, 250 µs, 1-4 mA for 15 minutes. Sham taVNS is delivered at 0 mA output for 15 minutes. A minimum washout period of 48 hours will be observed between visits
  • Device: transcutaneous auricular vagus nerve stimulation
    Participants will sit quietly while receiving active nerve stimulation for 15 minutes. A gentle electrical current is delivered through hydrogel electrodes placed in the ear. The active stimulation parameters are set to 30 Hz, 250 µs, and 0.1-4 mA.

Recruiting Locations

Wellness, Health and Research Facility at UAB
Birmingham, Alabama 35209
Contact:
Alex Evancho
205-975-5221
amelgin@uab.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Alexandra Evancho, DPT
205-975-5221
amelgin@uab.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.