Clinical trial NCT06642454: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Apathy
Sleep Disorder
Fatigue
Mood Disorders
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study employs a three-cycle crossover design to compare the effects of three different modes and frequencies of transcutaneous auricular vagus nerve stimulation (taVNS). The interventions include: 25 Hz non-expiratory gated taVNS, 25 Hz expiratory gated taVNS, and 100 Hz expiratory gated taVNS. Participants will be randomly assigned to one of three groups, with each group receiving a different intervention during each cycle, lasting 2 weeks per cycle. A 2-month washout period will be implemented between cycles to eliminate any carryover effects.The study design will include neuropsychological assessments, imaging, eye-tracking data collection, and biological specimen collection before and after each intervention.

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.

Primary outcomes:
measure: Non-Motor Symptoms Scale, Second Version (NMSS-2)
timeFrame: 2 weeks; 6 weeks; 10 weeks
Secondary outcomes:
measure: Apathy Motivation Index (AMI)
timeFrame: 2 weeks; 6 weeks; 10 weeks
measure: Apathy Evaluation Scale (AES)
timeFrame: 2 weeks; 6 weeks; 10 weeks
measure: Fatigue Scale-14 (FS-14)
timeFrame: 2 weeks; 6 weeks; 10 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 2 weeks; 6 weeks; 10 weeks
measure: REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)
timeFrame: 2 weeks; 6 weeks; 10 weeks
measure: Hamilton Anxiety Rating Scale (HAMA)
timeFrame: 2 weeks; 6 weeks; 10 weeks
measure: Hamilton Depression Rating Scale (HAMD-17)
timeFrame: 2 weeks; 6 weeks; 10 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: Cognitive Neuropsychology Lab Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: Cognitive Neuropsychology Lab Anhui Medical University
state: Anhui
Study officials:
References: