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

NCT07440563 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-05

No results posted yet for this study

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.

Conditions

  • PARKINSON DISEASE (Disorder)

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 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.

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-03
Primary Completion
2027-03-23
Completion
2027-04-23

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07440563 on ClinicalTrials.gov