Nerve Stimulation for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a gentle nerve stimulation technique, transcutaneous auricular vagus nerve stimulation (taVNS), can help people with Parkinson's Disease manage heart rate and blood pressure issues. These problems often hinder exercise and daily activities. The trial aims to determine if this non-invasive method can support physical therapy and improve overall function. Participants will switch between real and sham (inactive) treatments in two groups. People with Parkinson's who have maintained a stable medication routine for at least four weeks might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could enhance daily living for Parkinson's patients.
Do I need to stop taking my current medications for the trial?
You need to have stable medication for at least 4 weeks before joining the study, but you cannot use beta blockers. The trial does not specify if you need to stop other medications.
What prior data suggests that this nerve stimulation is safe for people with Parkinson's Disease?
Research has shown that transcutaneous auricular Vagus Nerve Stimulation (taVNS), a device used to gently stimulate the ear, is generally safe for people with Parkinson's Disease. Studies have found some minor side effects, but no serious problems have been linked to taVNS. Most participants tolerated this treatment well, handling it without major issues. Overall, based on past research, taVNS appears to be a safe option.12345
Why are researchers excited about this trial?
Researchers are excited about transcutaneous auricular vagus nerve stimulation (taVNS) for Parkinson's disease because it offers a non-invasive and targeted approach to treatment. Unlike standard therapies that often involve medications or deep brain stimulation, taVNS stimulates the vagus nerve through the ear, potentially reducing symptoms with fewer side effects. This method is unique because it could modulate brain activity without surgery, offering a new avenue for symptom management that is less intrusive and more accessible.
What evidence suggests that transcutaneous auricular vagus nerve stimulation is effective for Parkinson's Disease?
Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) might benefit people with Parkinson's Disease. Studies have found that taVNS can enhance movement and coordination, as well as non-motor symptoms like sleep and overall quality of life. It may also help manage heart rate and blood pressure, common issues for those with Parkinson's. Some research suggests that taVNS could enhance the effectiveness of physical therapy by improving the body's response during exercise. In this trial, participants will receive either active taVNS or sham taVNS to evaluate its effectiveness. While the results are promising, improvements in walking have been modest.12346
Are You a Good Fit for This Trial?
This trial is for people diagnosed with Parkinson's disease who have been on a stable medication routine for at least 4 weeks. It is not open to those without this diagnosis or whose medications have recently changed.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline assessments including autonomic symptom burden, symptom severity, and physical activity questionnaires
Treatment
Participants receive active and sham taVNS to assess changes in heart rate and blood pressure
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- transcutaneous auricular vagus nerve stimulation
Trial Overview
The study tests whether gentle, non-invasive nerve stimulation (taVNS) applied to the ear can help improve heart rate and blood pressure control in people with Parkinson's disease. The goal is to see if this could support physical therapy and daily activities.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Citations
Transcutaneous auricular vagus nerve stimulation in ...
taVNS could regulate brain activity, motor and mental functions, and autonomic nervous system activity in patients with stroke and Parkinson's ...
Analyzing the Effectiveness of Transcutaneous Auricular ...
Our results suggest that taVNS is only partially effective in improving gait dysfunction related to Parkinson's Disease, with slight increases in walk speed ...
Effect of Transcutaneous Auricular Vagus Nerve ...
In this randomised placebo-controlled trial, the investigators will include 30 PD (Parkinson's disease) patients with HY (Hoehn Yahr stage) >2 and L-dopa ...
Home-based transcutaneous auricular vagus nerve ... - PMC
TaVNS significantly improved motor symptoms, reflected as reduced MDS-UPDRS Ⅲ scores, and alleviated non-motor symptoms including quality of ...
Home-based transcutaneous auricular vagus nerve ...
TaVNS significantly improved motor symptoms, reflected as reduced MDS-UPDRS Ⅲ scores, and alleviated non-motor symptoms including quality of life and sleep ...
Transcutaneous auricular vagus nerve stimulation ...
taVNS treatment improved PD motor symptoms by increasing Ne in the right M1 and enhancing intracortical facilitation (ICF, ISI 10, and 15 ms).
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