Parkinson DiseaseNCT05456451
Effectiveness of Noninvasive Vagus Stimulation for Upper Extremity in Parkinson's Disease
A study testing noninvasive vagus nerve srimulation in people with Parkinson Disease and Upper Extremity Dysfunction, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Vagus nerve stimulation in the treatment of PD is a non-pharmacological intervention with the potential to improve gait, cognition, fatigue, and autonomic functions, but more evidence is needed for VSS in the treatment of PD. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Parkinson Disease, Upper Extremity Dysfunction, Tremor
- What is being tested?
- noninvasive vagus nerve srimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jul 2022to 25 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 40-65.
- Diagnosed with Parkinson's Disease by a specialist neurologist.
- Hoehn-Yahr stage 2-3.
- Having bilateral resting tremor of the hands.
- Being agreed to participate in the study.
Who cannot join
- Bilateral or unilateral previous injury to the vagus nerve (eg injury during carotid endarterectomy).
- Severe depression (Beck Depression Scale > 29)
- Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug.
- Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from following the protocol timeline.
- Pregnancy or planning to become pregnant or breast-feed during the study period.
- Botox injections or any other upper extremity rehabilitation within 6 months prior to treatment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Kucukcekmece, 34303
Merve Damla Korkmaz, M.D., +90(212) 404 15 00, mervedml@gmail.com
A. Kivanc Menekseoglu, M.D., kivancmenekseoglu@gmail.com
About this study
Official title: Investigation of the Effectiveness of Noninvasive Vagus Stimulation on Upper Extremity Functions in Parkinson's Disease
Vagus nerve stimulation in the treatment of PD is a non-pharmacological intervention with the potential to improve gait, cognition, fatigue, and autonomic functions, but more evidence is needed for VSS in the treatment of PD. The potential mechanisms of VSS in the improvement seen in PD are explained by increased cholinergic transmission, decreased neuroinflammation, and enhanced NE release.
In this study, it was aimed to investigate the effects of non-invasive vagus nerve stimulation to be applied to patients with Parkinson's disease on tremor and vagus nerve activity in patients.
The tremor and autonomic activations of the participants will be evaluated at pre and post treatment.
Read the detailed description
Vagus nerve stimulation in the treatment of PD is a non-pharmacological intervention with the potential to improve gait, cognition, fatigue, and autonomic functions, but more evidence is needed for VSS in the treatment of PD. The potential mechanisms of VSS in the improvement seen in PD are explained by increased cholinergic transmission, decreased neuroinflammation, and enhanced NE release.
5 patients who meet the inclusion criteria will be included in this prospectively planned study. As a vagus stimulation protocol, noninvasive auricular stimulation and stimulation frequency of 10 Hz, pulse width of 300 µs, biphasic application for 20 minutes will be applied to each patient 3 times on different days. Stimulations will be performed 3 times on 3 different days as the right ear, left ear and bilateral ear.
The tremor of the patients participating in the study will be evaluated with the smartphone application. After opening the phone application (G-Sensor), which is used to measure tremor, the patients will be asked to hold the phone in each hand at rest for 30 seconds and the tremor will be recorded. In this application, the maximum amplitude and frequency of the tremor in the 3D plane are calculated automatically.
The effect of vagus nerve stimulation on autonomic nervous system activity is evaluated using heart rate variability with Polar device.
The participants will be evaluated pre and post-treatment.
- Conditions
- Parkinson Disease, Upper Extremity Dysfunction, Tremor
- Being tested
- noninvasive vagus nerve srimulation
- Keywords
- vagus nerve stimulation, tremor, parkinson disease, upper extremity
- Medical subject headings
- Parkinson Disease, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noninvasive vagus nerve srimulationDevice
Non-invasive Vagus nerve stimulation (VNS) stimulates the vagus nerve through the ear via a headset. VNS is a non-pharmacological intervention with the potential to improve walking, cognition, fatigue, and autonomic functions in the treatment of Parkinson's disease.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson group(pre and post treatment) | Experimental | 5 participants will be evaluated for tremor and autonomic dysfunction at pre and post treatment Receives: Device: noninvasive vagus nerve srimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
tremor
The tremor of the patients participating in the study will be evaluated with the smartphone application. After opening the phone application (G-Sensor), which is used to measure tremor, the patients will be asked to hold the phone in each hand at rest for 30 seconds and the tremor will be recorded. In this application, the maximum amplitude and frequency of the tremor in the 3D plane are calculated automatically. This application provides the opportunity to evaluate tremor numerically in patients with tremor, and there are studies where it has been used before in Parkinson's disease.
Measured: 1 day
autonomic nervous system
The effect of vagus nerve stimulation on autonomic nervous system activity is evaluated using heart rate variability by using Polar device.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start25 Jul 2022 (estimated)
- Primary completion25 Sep 2022 (estimated)
- Study completion25 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The participants wit Parkinson disease, who has Hohen Yahr grade 2-3 will be included in the study.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sisli Hamidiye Etfal Training and Research Hospital, Acibadem Atakent University Hospital, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Responsible party
- Principal investigator, Merve Damla Korkmaz, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- E. Efe Is, M.D., Principal investigator, Sisli Hamidiye Etfal Training and Research HospitalCeyhun Basoglu, M.D., Principal investigator, Acibadem Atakent University HospitalMustafa Corum, M.D., Principal investigator, Istanbul Physical Medicine and Rehabilitation Training and Research HospitalAli Veysel Ozden, M.D., Principal investigator, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456451
- Sponsor's protocol ID
- 3616
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not decided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Noninvasive Vagus Stimulation on Upper Extremity Functions in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05456451
- Acronym / sponsor ID
- 3616
- Conditions
- Parkinson Disease, Upper Extremity Dysfunction, Tremor
- Keywords
- vagus nerve stimulation, tremor, parkinson disease, upper extremity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Collaborators
- Sisli Hamidiye Etfal Training and Research Hospital, Acibadem Atakent University Hospital, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Study start
- 25 Jul 2022 (estimated)
- Primary completion
- 25 Sep 2022 (estimated)
- Study completion
- 25 Oct 2022 (estimated)
- First posted
- 13 Jul 2022 (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.
Vagus nerve stimulation in the treatment of PD is a non-pharmacological intervention with the potential to improve gait, cognition, fatigue, and autonomic functions, but more evidence is needed for VSS in the treatment of PD. The potential mechanisms of VSS in the improvement seen in PD are explained by increased cholinergic transmission, decreased neuroinflammation, and enhanced NE release.
In this study, it was aimed to investigate the effects of non-invasive vagus nerve stimulation to be applied to patients with Parkinson's disease on tremor and vagus nerve activity in patients.
The tremor and autonomic activations of the participants will be evaluated at pre and post treatment.
Detailed description
Vagus nerve stimulation in the treatment of PD is a non-pharmacological intervention with the potential to improve gait, cognition, fatigue, and autonomic functions, but more evidence is needed for VSS in the treatment of PD. The potential mechanisms of VSS in the improvement seen in PD are explained by increased cholinergic transmission, decreased neuroinflammation, and enhanced NE release.
5 patients who meet the inclusion criteria will be included in this prospectively planned study. As a vagus stimulation protocol, noninvasive auricular stimulation and stimulation frequency of 10 Hz, pulse width of 300 µs, biphasic application for 20 minutes will be applied to each patient 3 times on different days. Stimulations will be performed 3 times on 3 different days as the right ear, left ear and bilateral ear.
The tremor of the patients participating in the study will be evaluated with the smartphone application. After opening the phone application (G-Sensor), which is used to measure tremor, the patients will be asked to hold the phone in each hand at rest for 30 seconds and the tremor will be recorded. In this application, the maximum amplitude and frequency of the tremor in the 3D plane are calculated automatically.
The effect of vagus nerve stimulation on autonomic nervous system activity is evaluated using heart rate variability with Polar device.
The participants will be evaluated pre and post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The participants wit Parkinson disease, who has Hohen Yahr grade 2-3 will be included in the study.
| Arm | Type | Receives |
|---|---|---|
| Parkinson group(pre and post treatment) | Experimental | Device: noninvasive vagus nerve srimulation5 participants will be evaluated for tremor and autonomic dysfunction at pre and post treatment |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being between the ages of 40-65.
- Diagnosed with Parkinson's Disease by a specialist neurologist.
- Hoehn-Yahr stage 2-3.
- Having bilateral resting tremor of the hands.
- Being agreed to participate in the study.
Key exclusion criteria (6 listed)
- Bilateral or unilateral previous injury to the vagus nerve (eg injury during carotid endarterectomy).
- Severe depression (Beck Depression Scale > 29)
- Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug.
- Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from following the protocol timeline.
- Pregnancy or planning to become pregnant or breast-feed during the study period.
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 |
|---|---|---|
| noninvasive vagus nerve srimulationNon-invasive Vagus nerve stimulation (VNS) stimulates the vagus nerve through the ear via a headset. VNS is a non-pharmacological intervention with the potential to improve walking, cognition, fatigue, and autonomic functions in the treatment of Parkinson's disease. | Device | Parkinson group(pre and post treatment) |
Primary outcome
tremor
Time frame: 1 day
The tremor of the patients participating in the study will be evaluated with the smartphone application. After opening the phone application (G-Sensor), which is used to measure tremor, the patients will be asked to hold the phone in each hand at rest for 30 seconds and the tremor will be recorded. In this application, the maximum amplitude and frequency of the tremor in the 3D plane are calculated automatically. This application provides the opportunity to evaluate tremor numerically in patients with tremor, and there are studies where it has been used before in Parkinson's disease.
autonomic nervous system
Time frame: 1 day
The effect of vagus nerve stimulation on autonomic nervous system activity is evaluated using heart rate variability by using Polar device.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Individual participant dataSharing planned: No. not decided
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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. This study is not recruiting at the moment.
E. Efe Is, M.D. principal investigator
Sisli Hamidiye Etfal Training and Research Hospital
Ceyhun Basoglu, M.D. principal investigator
Acibadem Atakent University Hospital
Mustafa Corum, M.D. principal investigator
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing noninvasive vagus nerve srimulation in people with Parkinson Disease and Upper Extremity Dysfunction, run by Kanuni Sultan Suleyman Training and Research Hospital 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: status not confirmed, as of the sponsor's last update on 13 Jul 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merve Damla Korkmaz, M.D. (+90(212) 404 15 00, mervedml@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tremor (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2022.