A Comparative Open-Label Crossover Study of Respiratory-Gated Versus Non-Respiratory-Gated Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Non-Motor Symptoms in Parkinson's Disease

Launched by ANHUI MEDICAL UNIVERSITY · Oct 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at different ways to use a treatment called transcutaneous auricular vagus nerve stimulation (taVNS) for people with Parkinson's disease. Specifically, the researchers want to find out which method and frequency of this treatment works best for improving non-motor symptoms like apathy, sleep problems, fatigue, and mood disorders. They will compare three types of taVNS: one that focuses on breathing out, one that focuses on breathing in, and one that works at a higher frequency. Participants will try each method over three 2-week periods and will undergo various assessments before and after each treatment cycle.

To join this trial, participants need to be at least 40 years old and have a confirmed diagnosis of Parkinson's disease. They should be stable on their medications for at least two weeks and be in good mental health to complete the required tests. Those interested in participating will not only receive the treatment but also undergo tests to gauge how well the treatment is working and ensure their safety. The trial is currently recruiting participants, so if you or someone you know fits these criteria, it might be a good opportunity to explore new treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: 40 years or older.
• • Confirmed diagnosis of Parkinson's disease (PD) per the United Kingdom Brain Bank Criteria by a neurologist specialized in movement disorders.
• • Participants must be on a stable dose of all medications for at least 2 weeks, with no planned adjustments to anti-PD medications for the next 3 months.
• • In the second version of the Non-Motor Symptoms Scale (NMSS-2) for Parkinson's disease, a score of ≥1 is assigned to either question 4 or question 8.
• • Participants must be in good mental health and capable of completing behavioral tests and transcutaneous auricular vagus nerve stimulation.
• Exclusion Criteria:
• • Mini-Mental State Examination (MMSE) score \<24.
• • History of head injury, stroke, or other neurological disorders.
• • Includes implanted cardiac pacemakers post-DBS operation, local infections, ear loss, or metal implants at the stimulation site.
• • Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.
• • Inability to complete follow-up assessments.