A Randomized Double-Blind Active-Controlled Crossover Trial of Respiratory-Gated Versus Non-Gated Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Motor and Non-Motor Symptoms in Parkinson's Disease
NCT ID: NCT06642454
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
30 participants
INTERVENTIONAL
2024-10-01
2027-04-01
Brief Summary
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Which mode and frequency of taVNS is most effective in improving motor or 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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25 Hz non-expiratory gated taVNS
25 Hz non-expiratory gated transcutaneous auricular vagus nerve stimulation
Transcutaneous auricular vagus nerve stimulation
Stimulation Target: Left cymba conchae.
25 Hz Non-Expiratory Gated taVNS: Stimulation is delivered for 30 seconds at a frequency of 25 Hz, followed by a 30-second interval.
25 Hz Expiratory Gated taVNS: One second of stimulation occurs during exhalation at a frequency of 25 Hz.
100 Hz Expiratory Gated taVNS: One second of stimulation is administered during exhalation at a frequency of 100 Hz.
25 Hz expiratory gated taVNS
25 Hz expiratory gated transcutaneous auricular vagus nerve stimulation
Transcutaneous auricular vagus nerve stimulation
Stimulation Target: Left cymba conchae.
25 Hz Non-Expiratory Gated taVNS: Stimulation is delivered for 30 seconds at a frequency of 25 Hz, followed by a 30-second interval.
25 Hz Expiratory Gated taVNS: One second of stimulation occurs during exhalation at a frequency of 25 Hz.
100 Hz Expiratory Gated taVNS: One second of stimulation is administered during exhalation at a frequency of 100 Hz.
100 Hz expiratory gated taVNS
100 Hz expiratory gated transcutaneous auricular vagus nerve stimulation
Transcutaneous auricular vagus nerve stimulation
Stimulation Target: Left cymba conchae.
25 Hz Non-Expiratory Gated taVNS: Stimulation is delivered for 30 seconds at a frequency of 25 Hz, followed by a 30-second interval.
25 Hz Expiratory Gated taVNS: One second of stimulation occurs during exhalation at a frequency of 25 Hz.
100 Hz Expiratory Gated taVNS: One second of stimulation is administered during exhalation at a frequency of 100 Hz.
Interventions
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Transcutaneous auricular vagus nerve stimulation
Stimulation Target: Left cymba conchae.
25 Hz Non-Expiratory Gated taVNS: Stimulation is delivered for 30 seconds at a frequency of 25 Hz, followed by a 30-second interval.
25 Hz Expiratory Gated taVNS: One second of stimulation occurs during exhalation at a frequency of 25 Hz.
100 Hz Expiratory Gated taVNS: One second of stimulation is administered during exhalation at a frequency of 100 Hz.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
80 Years
ALL
No
Sponsors
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Anhui Medical University
OTHER
Responsible Party
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WANG KAI
Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC
Locations
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Cognitive Neuropsychology Lab Anhui Medical University
Hefei, Anhui, China
Cognitive Neuropsychology Lab Anhui Medical University
Hefei, Anhui, China
Countries
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Other Identifiers
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PD-TaVNS-OPEN
Identifier Type: -
Identifier Source: org_study_id