The Effect and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation on Gait Impairments in PD

Study Overview
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Brief Summary
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This study is a double blind comparative study examining the effectiveness of the transcutaneous auricular vagus nerve stimulation treatment on Parkinson's disease patients . We hypothesize that treatment using transcutaneous auricular vagus nerve stimulation will improve gait impairments and cortical activity in Parkinson's disease patients.

Detailed Description
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Patients in the Experimental group underwent seven consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time) , whereas patients in the sham stimulation group underwent seven consecutive daily sessions of sham taVNS. Assessments of gait function, motor symptoms and cortical activity (using Functional near-infrared spectroscopy) were performed two times: at baseline, one day post intervention.

Official Title
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Study on the Therapeutic Effect and Brain Mechanism of Transcutaneous Vagal Nerve Stimulation on Gait Impairments in Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Transcutaneous auricular vagus nerve stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist. Hoehn and Yahr stage ≤ 2 during ON medication state. Age between 40 and 80 years old. Mini-Mental State Examination score >24. Ability to walk at least 60s independently. Stable medication Exclusion Criteria: Patients with significant visual impairment or coexisting local or systemic diseases (e.g. osteoarthritis or other neurological conditions) likely to affect gait were excluded from our study. Patients who underwent deep brain stimulation surgery or those with an implanted cardiac pacemaker were also excluded Patients with known or suspected cardiovas-cular disease, uncontrolled hypertension or recent myocardial infarction were also excluded from the study.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active transcutaneous auricular vagus nerve stimulation<br>For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent seven consecutive daily sessions of taVNS. | Device: Transcutaneous auricular vagus nerve stimulation<br>* Transcutaneous auricular vagus nerve stimulation was conducted by transcutaneous electrical stimulation therapy instrument to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve. Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs, twice a day, 30 minutes each time. In the sham stimulation group, the electrodes were fixed at the same position without releasing current.<br>|
| Sham Comparator: sham transcutaneous auricular vagus nerve stimulation<br>For sham transcutaneous auricular vagus nerve stimulation arm, Sham Comparator, patients underwent seven consecutive daily sessions of sham-taVNS (the electrodes were fixed at the same position without releasing current). | Device: Transcutaneous auricular vagus nerve stimulation<br>* Transcutaneous auricular vagus nerve stimulation was conducted by transcutaneous electrical stimulation therapy instrument to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve. Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs, twice a day, 30 minutes each time. In the sham stimulation group, the electrodes were fixed at the same position without releasing current.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Velocity at one day post intervention | The velocity will be recorded in cm/s. | Assessed at baseline, one day post intervention | 
| Change from Baseline Step length at one day post intervention | The step length will be recorded in meters. | Assessed at baseline, one day post intervention. | 
| Change from Baseline arm ROM maximum at one day post intervention | The arm ROM maximum will be recorded in degree. | Assessed at baseline, one day post intervention. | 
| Change from Baseline turning average duration velocity at one day post intervention | The turning average duration velocity will be recorded in cm/s. | Assessed at baseline, one day post intervention. | 
| Change from Baseline gait cycle at one day post intervention | The gait cycle will be recorded in s. | Assessed at baseline, one day post intervention. | 
| Change from Baseline Unified Parkinson's Disease Rating Scale-III at one day post intervention | The measure mainly reflects the overall severity of Parkinson's disease motor symptoms. | Assessed at baseline, one day post intervention. | 
| Changes in Tinetti Gait scores at one day post intervention | This indicator mainly reflects the stability of posture . | Assessed at baseline, one day post intervention. | 
| Changes in Tinetti Balance scores at one day post intervention | This indicator mainly reflects the stability of gait. | Assessed at baseline, one day post intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in ΔHbO2 concentration in the brain cortex | The ΔHbO2 concentration in the brain cortex will be recorded in oxyhemoglobin. | Assessed at baseline, one day post intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gait, Therapeutics