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

NCT07440563 | Enrolling By Invitation

• 1 other identifier: 2025 - 1202
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Parkinson's disease; rehabilitation; vagus nerve stimulation; balance; gait

Outcome Measures

Primary Outcomes (4)

• Movement Disorders Society-Unified Parkinson's Disease Rating Scale

  The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) was used to assess motor and non-motor symptom severity in individuals with Parkinson's disease. The MDS-UPDRS is a validated, comprehensive clinical rating scale consisting of four parts: non-motor experiences of daily living (Part I), motor experiences of daily living (Part II), motor examination (Part III), and motor complications (Part IV). Higher scores indicate greater symptom severity. The scale has demonstrated excellent reliability, validity, and sensitivity to change in clinical trials and is widely recommended as a primary outcome measure in Parkinson's disease research.

  twice: once on the initial assessment day and once after the 3-week program.

• Postural Stability

  The force platform, considered the gold standard for the quantitative assessment of postural stability, is a valid and reliable method that enables objective evaluation of balance. In this study, postural stability during quiet standing will be assessed using a force platform. Participants will stand on the platform in a standardized foot position, with their arms at their sides and their gaze fixed forward. Measurements will be performed under eyes-open and eyes-closed conditions. For each condition, trials of fixed duration will be recorded, and center of pressure (CoP) parameter will be calculated. Higher CoP value will indicate reduced postural stability. Measurements will be repeated according to a standardized protocol, and the average values will be used for analysis.

  twice: once on the initial assessment day and once after the 3-week program.

• Spatiotemporal Gait Parameters

  Spatiotemporal gait characteristics will be evaluated using a gait analysis system. Participants will walk across the walkway six times at their self-selected comfortable speed. Temporal and spatial parameters (step length, stride length, step time, stride time, double support time) of gait, as well as variability measures, will be calculated.

  twice: once on the initial assessment day and once after the 3-week program.

• Functional Walking Capacity

  Functional walking capacity will be assessed using the 6-Minute Walk Test (6MWT). Participants will be instructed to walk as far as possible within six minutes along a standardized walkway. The total distance covered will be recorded in meters. In individuals with Parkinson's disease, the minimal clinically important difference has been reported as 82 meters.

  twice: once on the initial assessment day and once after the 3-week program.

Secondary Outcomes (7)

• Berg Balance Sclae

  twice: once on the initial assessment day and once after the 3-week program.

• Activities-specific Balance Confidence Scale

  twice: once on the initial assessment day and once after the 3-week program.

• Functional Mobility

  twice: once on the initial assessment day and once after the 3-week program.

• Trail Making Test

  twice: once on the initial assessment day and once after the 3-week program.

• Stroop Test

  twice: once on the initial assessment day and once after the 3-week program.

Study Arms (2)

Active Auricular Vagus Nerve Stimulation Group

EXPERIMENTAL

Other: Neurological Physiotherapy and Rehabilitation Combined with Active Vagus Nerve Stimua

Sham Auricular Vagus Nerve Stimulation Group

SHAM COMPARATOR

Other: Neurological Physiotherapy and Rehabilitation Combined with Sham Vagus Nerve Stimua

Interventions

Neurological Physiotherapy and Rehabilitation Combined with Active Vagus Nerve Stimua OTHER

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.

Active Auricular Vagus Nerve Stimulation Group

Neurological Physiotherapy and Rehabilitation Combined with Sham Vagus Nerve Stimua OTHER

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.

Sham Auricular Vagus Nerve Stimulation Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Please Select, 06490, Turkey (Türkiye)

Location

Related Publications (2)

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Parkinson Disease

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants in the study will not be informed that the vagus nerve stimulation being administered is sham. The physiotherapist responsible for the rehabilitation program will provide the same program to both groups and conduct the evaluations. Participants will not be informed about vagus nerve stimulation. The groups will be blinded to the treatment results, and statistical analyses will be performed by a blind evaluator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 27, 2026
• Study Start: March 3, 2026
• Primary Completion (Estimated): March 23, 2027
• Study Completion (Estimated): April 23, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

TU (1)