Effectiveness of Noninvasive Vagus Stimulation for Upper Extremity in Parkinson's Disease (NCT05456451) | Clinical Trial Compass
UnknownNot Applicable
Effectiveness of Noninvasive Vagus Stimulation for Upper Extremity in Parkinson's Disease
Turkey (Türkiye)5 participantsStarted 2022-07-25
Plain-language 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. 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.
Who can participate
Age range
40 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
tremor
Timeframe: 1 day
2
autonomic nervous system
Timeframe: 1 day
Trial details
NCT IDNCT05456451
SponsorKanuni Sultan Suleyman Training and Research Hospital