Auricular Vagus Nerve Stimulation Combined With Rehabilitation in Parkinson's Disease

Official title

Investigation of the Effects of Auricular Vagus Nerve Stimulation Combined With Neurological Physiotherapy and Rehabilitation on Balance, Gait, and Clinical Symptoms in People With Parkinson's Disease

Overview

Parkinson's disease (PD) is a progressive, neurodegenerative movement disorder characterized by a combination of motor and non-motor symptoms. Auricular vagus nerve stimulation (aVNS), one of the physiotherapy methods used in PD, has been shown in studies to have a positive effect on symptoms such as motor symptoms, gait disturbance, freezing, and cognitive impairment, and is considered a safe and feasible method. The aim of this study is to investigate the effects of neurological physiotherapy and rehabilitation, in combination with aVNS application, on balance, gait, and clinical symptoms in individuals with PD.

Detailed description

Parkinson's disease (PD) is a progressive, neurodegenerative movement disorder characterized by a combination of motor symptoms such as bradykinesia, rigidity, tremor, and postural instability, and non-motor symptoms such as depression, anxiety, and cognitive impairment. Neurological physiotherapy and rehabilitation are among the most important components of PD in the literature to prevent progression, alleviate symptoms, and slow neurodegeneration. Auricular vagus nerve stimulation (aVNS), one of the physiotherapy methods used in PD, has been shown in studies to have a positive effect on symptoms such as motor symptoms, gait disturbance, freezing, and cognitive impairment, and is considered a safe and feasible method. Looking at PD studies in the literature, it is seen that participants applied aVNS at home on their own, in an isolated study design, and individuals were not included in any rehabilitation program. The aim of this study is to investigate the effects of neurological physiotherapy and rehabilitation, in combination with aVNS application, on balance, gait, and clinical symptoms in individuals with PD. The study will include individuals diagnosed with Parkinson's disease. Individuals will be divided into two groups: a control group and a study group. In this blinded study, individuals in both groups will be included in a physiotherapy and rehabilitation program at the Neurological Physiotherapy and Rehabilitation Unit. Individuals in the control group will receive sham aVNS, while individuals in the active treatment group will receive active aNVS. Individuals will be evaluated twice, before and after their three-week, five-day-a-week program. Balance, gait, and clinical symptoms will be assessed using tests and scales.

Interventions

• Other Neurological Physiotherapy and Rehabilitation Combined with Active Vagus Nerve Stimua
  Individuals will be enrolled in an intensive and individualized physiotherapy and rehabilitation program for three weeks, consisting of 15 sessions in total, five days a week. This program is primarily structured to include exercises and functional task activities recommended in PD guidelines for patients' exercise routines, and previously demonstrated in neurological rehabilitation clinics to improve balance and gait. The goals of the program are to increase strength and flexibility of large mu
• Other Neurological Physiotherapy and Rehabilitation Combined with Sham Vagus Nerve Stimua
  Individuals will be enrolled in an intensive and individualized physiotherapy and rehabilitation program for three weeks, consisting of 15 sessions in total, five days a week. This program is primarily structured to include exercises and functional task activities recommended in PD guidelines for patients' exercise routines, and previously demonstrated in neurological rehabilitation clinics to improve balance and gait. The goals of the program are to increase strength and flexibility of large mu

Primary outcome measures

• Movement Disorders Society-Unified Parkinson's Disease Rating Scale [Time frame: twice: once on the initial assessment day and once after the 3-week program.]
• Postural Stability [Time frame: twice: once on the initial assessment day and once after the 3-week program.]
• Spatiotemporal Gait Parameters [Time frame: twice: once on the initial assessment day and once after the 3-week program.]
• Functional Walking Capacity [Time frame: twice: once on the initial assessment day and once after the 3-week program.]

Secondary outcome measures (7)

• Berg Balance Sclae [Time frame: twice: once on the initial assessment day and once after the 3-week program.]
• Activities-specific Balance Confidence Scale [Time frame: twice: once on the initial assessment day and once after the 3-week program.]
• Functional Mobility [Time frame: twice: once on the initial assessment day and once after the 3-week program.]
• Trail Making Test [Time frame: twice: once on the initial assessment day and once after the 3-week program.]
• Stroop Test [Time frame: twice: once on the initial assessment day and once after the 3-week program.]
• Quality of Life Assessment [Time frame: twice: once on the initial assessment day and once after the 3-week program.]
• Fatigue Assessment [Time frame: twice: once on the initial assessment day and once after the 3-week program.]

Eligibility criteria

Inclusion criteria

• Diagnosis of Parkinson's disease confirmed by a neurologist according to the United Kingdom Brain Bank criteria
• Age 40 years or older
• Hoehn and Yahr stage between 1 and 3 according to the Modified Hoehn and Yahr Staging Scale
• Stable pharmacological treatment regimen
• Ability to turn 180 degrees and walk 30 meters independently without assistance

Exclusion criteria

• Score below 21 on the Montreal Cognitive Assessment (MoCA)
• Presence of uncorrected visual or hearing impairments
• Presence of additional neurological (e.g., migraine), orthopedic (e.g., osteoarthritis), or cardiovascular conditions (e.g., myocardial infarction, uncontrolled hypertension, arrhythmias)
• Presence of a cardiac pacemaker
• Presence of metallic implants in the head or neck region
• History of deep brain stimulation surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Gazi University — Ankara

Publications

• Eissazade N, Eghdami S, Rohani M, Ajdari A, Fereshtehnejad SM, Fasano A, Khoeini T. Noninvasive Vagus Nerve Stimulation in Parkinson's Disease: A Systematic Review. Neuromodulation. 2025 Jun;28(4):641-651. doi: 10.1016/j.neurom.2025.01.012. Epub 2025 Mar 6. PMID 40057881
• Sigurdsson HP, Raw R, Hunter H, Baker MR, Taylor JP, Rochester L, Yarnall AJ. Noninvasive vagus nerve stimulation in Parkinson's disease: current status and future prospects. Expert Rev Med Devices. 2021 Oct;18(10):971-984. doi: 10.1080/17434440.2021.1969913. Epub 2021 Sep 8. PMID 34461787

Identifiers

NCT: NCT07440563 · 2025 - 1202

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗