Nerve Stimulation for Parkinson's Disease

Overseen By Alexandra Evancho, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Beta blockers

Disqualifiers: Severe hypertension, Cardiac arrhythmia, Angina, Heart failure, Myocardial infarction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1-2 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with idiopathic Parkinson's disease.

* Stable medication for at least 4 weeks prior to the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Baseline assessments including autonomic symptom burden, symptom severity, and physical activity questionnaires

1 week

1 visit (in-person)

Treatment

Participants receive active and sham taVNS to assess changes in heart rate and blood pressure

1-2 weeks

2 visits (in-person) with a 48-hour washout period between visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• transcutaneous auricular vagus nerve stimulation

How Is the Trial Designed?

Group I: Group 2 Experimental Treatment 1 Intervention

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

Group II: Group 1 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+