PARKINSON DISEASE (Disorder)NCT07440563
Auricular Vagus Nerve Stimulation Combined With Rehabilitation in Parkinson's Disease
A study testing Neurological Physiotherapy and Rehabilitation Combined with Active Vagus Nerve Stimua in people with PARKINSON DISEASE (Disorder), run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- Neurological Physiotherapy and Rehabilitation Combined with Active Vagus Nerve Stimua
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2026to 23 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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)
- Being tested
- Neurological Physiotherapy and Rehabilitation Combined with Active Vagus Nerve Stimua, Neurological Physiotherapy and Rehabilitation Combined with Sham Vagus Nerve Stimua
- Keywords
- Parkinson's disease, rehabilitation, vagus nerve stimulation, balance, gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurological Physiotherapy and Rehabilitation Combined with Active Vagus Nerve StimuaOther
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.
Neurological Physiotherapy and Rehabilitation Combined with Sham Vagus Nerve StimuaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Auricular Vagus Nerve Stimulation Group | Experimental | Not described Receives: Other: Neurological Physiotherapy and Rehabilitation Combined with Active Vagus Nerve Stimua |
| Sham Auricular Vagus Nerve Stimulation Group | Sham comparator | Not described Receives: Other: Neurological Physiotherapy and Rehabilitation Combined with Sham Vagus Nerve Stimua |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: twice: once on the initial assessment day and once after the 3-week program.
Secondary outcomes (7)
Berg Balance Sclae
Functional balance will be assessed using the Berg Balance Scale (BBS), a widely used and validated clinical scale for the evaluation of balance performance in individuals with neurological conditions. The BBS consists of 14 functional tasks, including sitting, standing, transfers, reaching, turning, and single-leg stance. Each item is scored on a 5-point ordinal scale ranging from 0 to 4, with a maximum total score of 56 points. Higher scores indicate better balance performance. The BBS has demonstrated high reliability, validity, and sensitivity to change in individuals with Parkinson's disease and other neurological populations.
Measured: twice: once on the initial assessment day and once after the 3-week program.
Activities-specific Balance Confidence Scale
Balance confidence will be assessed using the Activities-specific Balance Confidence Scale (ABC). The ABC is a self-reported questionnaire designed to evaluate an individual's confidence in maintaining balance during various daily activities. It consists of 16 items, each scored from 0% (no confidence) to 100% (complete confidence). The overall score is calculated as the average of all item scores, with higher values indicating greater balance confidence. The ABC has demonstrated good reliability, validity, and responsiveness in individuals with Parkinson's disease and other neurological populations.
Measured: twice: once on the initial assessment day and once after the 3-week program.
Functional Mobility
Functional mobility will be assessed using the Timed Up and Go Test (TUG). In this test, participants are instructed to stand up from a chair on the command "go," walk 3 meters, turn around, walk back, and sit down again. The test is performed on a flat, unobstructed 3-meter walkway. Timing begins at the command "go" and stops when the participant sits back in the chair. A chair with armrests will be used (seat height: 50 cm, seat depth: 47 cm, seat width: 50 cm, armrest height: 65 cm). One practice trial will be performed, followed by two recorded trials, and the final measurement will be used for analysis.
Measured: twice: once on the initial assessment day and once after the 3-week program.
Trail Making Test
The Trail Making Test (TMT) is used to assess executive functions, task-switching ability, attention, visual scanning speed, visuomotor processing, planning, organization, abstract thinking, and response inhibition. The test consists of two parts: Part A (TMT-A) and Part B (TMT-B). In Part A, participants are asked to connect numbered circles in sequential order from 1 to 25, and the completion time is recorded. In Part B, participants are required to alternate between numbers and letters in sequence (e.g., 1-A-2-B-3-C), and the completion time is recorded.
Measured: twice: once on the initial assessment day and once after the 3-week program.
Stroop Test
The Stroop Test is a cognitive assessment that evaluates executive functions, particularly selective attention, cognitive flexibility, and the ability to inhibit automatic responses under interference conditions. In this study, the Stroop Test-Basic Sciences Research Group Form (ST-BSRG) will be used. This form is a combined version of the original Stroop Test and the Victoria version. The test is administered in five sections using four different cards. Each card contains six rows, with each row consisting of four items arranged in sequence. The completion time and errors are recorded for analysis.
Measured: twice: once on the initial assessment day and once after the 3-week program.
Quality of Life Assessment
Quality of life will be evaluated using the Parkinson's Disease Questionnaire-8 (PDQ-8). The PDQ-8 is a short-form, disease-specific questionnaire that assesses the impact of Parkinson's disease on quality of life. The items evaluate the individual's experiences over the previous month and are scored on a scale from 0 (never) to 4 (always). The total score is converted to a 0-100 scale, with higher scores indicating poorer quality of life. The Turkish version of the PDQ-8 has been shown to be valid and reliable, with excellent test-retest reliability (ICC = 0.97) as reported by Kahraman and colleagues.
Measured: twice: once on the initial assessment day and once after the 3-week program.
Fatigue Assessment
Subjective fatigue will be evaluated using the Parkinson Fatigue Scale (PFS). The PFS consists of 16 items and is rated on a five-point Likert scale. It was specifically developed to assess fatigue related to Parkinson's disease. Each item is scored from "strongly disagree" to "strongly agree," with higher scores indicating greater fatigue severity. The Turkish version of the scale has been shown to be valid and reliable.
Measured: twice: once on the initial assessment day and once after the 3-week program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start3 Mar 2026
- Primary completion23 Mar 2027 (estimated)
- Study completion23 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Can Salamci, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440563
- Sponsor's protocol ID
- 2025 - 1202
- Status last verified
- Mar 2026
- First submitted
- 16 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 40057881Sigurdsson 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.
PubMed 34461787
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07440563
- Acronym / sponsor ID
- 2025 - 1202
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- Parkinson's disease, rehabilitation, vagus nerve stimulation, balance, gait
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 23 Mar 2027 (estimated)
- Study completion
- 23 Apr 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurological Physiotherapy and Rehabilitation Combined with Active Vagus Nerve StimuaIndividuals 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 | Active Auricular Vagus Nerve Stimulation Group |
| Neurological Physiotherapy and Rehabilitation Combined with Sham Vagus Nerve StimuaIndividuals 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. | Other | Sham Auricular Vagus Nerve Stimulation Group |
Primary outcome
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.
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.
Postural Stability
Time frame: twice: once on the initial assessment day and once after the 3-week program.
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.
Spatiotemporal Gait Parameters
Time frame: twice: once on the initial assessment day and once after the 3-week program.
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.
Functional Walking Capacity
Time frame: twice: once on the initial assessment day and once after the 3-week program.
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.
7 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Results publication: PubMed 40057881Eissazade 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.
- Results publication: PubMed 34461787Sigurdsson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurological Physiotherapy and Rehabilitation Combined with Active Vagus Nerve Stimua in people with PARKINSON DISEASE (Disorder), run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07440563, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.