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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to compare the effects of different modes and frequencies of transcutaneous auricular vagus nerve stimulation (taVNS) on non-motor symptoms in people with Parkinson's disease. The main questions it aims to answer are: Which mode and frequency of taVNS is most effective in improving non-motor symptoms? Are there any side effects or safety concerns with different taVNS frequencies? Researchers will compare three types of taVNS: 25 Hz non-expiratory gated, 25 Hz expiratory gated, and 100 Hz expiratory gated stimulation. Participants will: Receive each type of taVNS in three 2-week cycles, with 2-month breaks between cycles Undergo neuropsychological assessments, imaging, eye-tracking, and biological sample collection before and after each cycle.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Cognitive Neuropsychology Lab Anhui Medical University
RECRUITING
Hefei
Cognitive Neuropsychology Lab Anhui Medical University
RECRUITING
Hefei
Contact Information
Primary
Rong Ye, Ph.D.
ronye.uk@gmail.com
+8615656050129
Backup
Kai Wang, Ph.D.
wangkai1964@126.com
+8655162923704
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 30
Treatments
Experimental: 25 Hz non-expiratory gated taVNS
25 Hz non-expiratory gated transcutaneous auricular vagus nerve stimulation
Experimental: 25 Hz expiratory gated taVNS
25 Hz expiratory gated transcutaneous auricular vagus nerve stimulation
Experimental: 100 Hz expiratory gated taVNS
100 Hz expiratory gated transcutaneous auricular vagus nerve stimulation
Related Therapeutic Areas
Sponsors
Leads: Anhui Medical University

This content was sourced from clinicaltrials.gov