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

The First Affiliated Hospital with Nanjing Medical University30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson Disease

Interventions

Transcutaneous auricular vagus nerve stimulationDEVICE

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist. 2. Hoehn and Yahr stage ≤ 2 during ON medication state. 3. Age between 40 and 80 years old. 4. Mini-Mental State Examination score \>24. 5. Ability to walk at least 60s independently. 6. Stable medication Exclusion Criteria: 1. 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. 2. Patients who underwent deep brain stimulation surgery or those with an implanted cardiac pacemaker were also excluded 3. Patients with known or suspected cardiovas-cular disease, uncontrolled hypertension or recent myocardial infarction were also excluded from the study.

Locations (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

Change from Baseline Velocity at one day post intervention

The velocity will be recorded in cm/s.

Time frame: 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.