NCT07440563

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Gazi University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• PARKINSON DISEASE (Disorder)

Interventions

Type	Name	Description
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 muscle groups, improve large and coordinated movement skills, postural accuracy, aerobic capacity, balance, and gait. The intensive and individualized physiotherapy and rehabilitation program will last approximately 90-120 minutes. The current form of the aVSS application received by the participants is a monophasic square wave. The current transit time is 250 milliseconds, the frequency is 25 Hertz, and the intensity is submaximal sensory perception.
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 muscle groups, improve large and coordinated movement skills, postural accuracy, aerobic capacity, balance, and gait. The intensive and individualized physiotherapy and rehabilitation program will last approximately 90-120 minutes. The vagus nerve stimulation device will not turn on.

Timeline

• Start date: 2026-03-03
• Primary completion: 2027-03-23
• Completion: 2027-04-23
• First posted: 2026-02-27
• Last updated: 2026-03-05

Locations

1 site across 1 country: Turkey (Türkiye)