Non-invasive Vagus Nerve Stimulation for Parkinson's Disease (VNS)
Although breakthroughs in the management of Parkinson's disease (PD) have emerged in recent decades resulting in better control in symptoms, majority of patients with PD are still living with various disabling motor and non-motor symptoms despite they are already receiving the best contemporary medical or surgical treatments available to them. There is obviously a need to develop additional treatment modality to further optimize the control of symptoms and/or slow the disease progression for patients having PD.
Vagus nerve stimulation (VNS), a type of noninvasive brain stimulation is believed to modify brain rhythms by modulating the nucleus of the solitary tract and locus coeruleus and other regions known to play a role in gait. Moreover, VNS may modulate inflammatory pathways and reduce oxidative stress, making it a potential disease modifying treatment approach for neurodegenerative diseases linked to neuroinflammation such as PD
Further study is warranted to explore the efficacy of non-invasive VNS for its effects on gait and other symptoms of PD as well as the anti-inflammatory effects.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
The objective of the present study is to investigate the feasibility, safety, and potential efficacy of 2 different non-invasive VNS stimulation protocols (conventional and exploratory) for patients with PD. The immediate effects of VNS as well as the medium-term effects of daily VNS at 2 and 4 weeks poststimulation, and the delayed effects of non-invasive VNS at 8 weeks of both stimulation protocols will be investigated. The effects of non-invasive VNS of the 2 different stimulation protocols will also be compared with sham stimulation. The study will be a randomized single blind study. The tested subjects, not the assessor, will be kept unaware of which treatment protocols they are receiving.
The investigator hypothesize the VNS stimulations may provide immediate effects, medium term effects and delayed effects.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Pauline Kwan, Master's Degree
- Telefonní číslo: +852 26352160
- E-mail: paulinekwan@cuhk.edu.hk
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
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Idiopathic PD as defined by the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria
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Age 40 - 75 years old
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Presence of gait impairment as defined by any one of the below:
a UPDRS Part 2 Item 15 (Walking) with a score of 2 b. UPDRS Part 3 Item 26 (leg Agility) with score of 2 or 3 c. UPDRS Part 3 Item 29 (Gait) with score of 1 or 2
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Availability of a caregiver at home
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Cantonese speaker
Exclusion Criteria:
- Patients with atypical parkinsonism (e.g., multiple system atrophy, progressive supranuclear palsy, dementia with Lewy Bodies)
- PD with dementia
- PD patients with DBS in-situ
- Severe PD with a Hoehn and Yahr staging of 4 or above
- Low blood pressure with systolic of < 110 mmHg or with postural hypotension as defined by a decrease in systolic and diastolic blood pressure by 20 mmHg and 10mmHg upon standing, respectively)
- Cardiac pacemaker in-situ
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: conventional VNS
Parkinson Disease |
The cVNS emits a low-voltage 5.56 KHz sinusoidal wave electrical signal bursts lasting 0.9 ms via two flat stimulation contact surfaces. (Figure 2) These bursts repeat once every 38 millisecond (ms). Each set of stimulation will be applied for 2 minutes. Stimulation current can be self-adjusted by the subject. This conventional stimulation waveform was approved by the US FDA for the treatment of migraines. |
|
Aktivní komparátor: exploratory VNS
|
The eVNS emits the company-proprietary low-voltage of 3~8 KHz sine-variant smooth-transition wave electrical signal bursts lasting near 0.9 ms via two flat stimulation contact surfaces. These bursts repeat once in intervals of approximately 40 ms. A potential benefit of this waveform is that it can produce less unpleasant skin sensations at a given current intensity and this may enhance the subject to tolerate higher current intensity than that of the conventional stimulation. |
|
Falešný srovnávač: sham VNS
|
The sVNS delivers mechanical motor vibrations to provide a similar perceptible stimulation feeling to the skin. No electrical stimulations are delivered. The device that delivers the sham stimulation is identical in appearance, weight, and user interface. A button to adjust "stimulation current" is also available in the sham device so as to allow the subject/caregiver to adjust the "stimulation current" |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change of gait
Časové okno: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
|
Timed UP and Go test: Participant sits back in a standard armchair with their back against the chair and hands resting on the armrests. Regular footwear and usual walking aids (like a cane or walker) are used. On the word "Go", the person stands up, walks a distance of 3 meters (10 feet) to a marked line or cone at a normal, safe pace, turns around, walks back to the chair, and sits down again. A stopwatch starts the moment the word "Go" is spoken and stops the moment the person's buttocks touch the seat. The results in second will be interpret to assist mobility and risk of falling. The longer the time, the high risk of fall |
Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
|
|
Severity and progression of Parkinson's disease
Časové okno: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
|
Using Unified Parkinson's Disease Rating Scale to motor and non-motor symptoms. Score from 0 to 4. 0 is normal while 4 is severe/marked impairment |
Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
|
|
Quantitative Gait Assessment
Časové okno: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
|
Using an app to track the mobility of participants in a 20 sec walking |
Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
|
|
Cognitive status
Časové okno: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
|
Using Hong Kong Montreal Cognitive Assessment to evaluate the cognitive status. score from 0-30. The lower the score, the more cognitive impaired. |
Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
|
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Change in mood
Časové okno: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
|
Using Geriatric depression scale which contain 15 questions. Score from 0-15. The higher the score, the more severe the depressed mood |
Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change of blood pressure
Časové okno: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
|
Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
|
|
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Safety measures- record of adverse event and serious adverse event
Časové okno: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
|
To investigate any possibility and relativity of AE and SAE with the treatment |
Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
|
|
Electrocardiogram
Časové okno: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
|
To investigate any possibility and relativity of the change of ECG with the treatment |
Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
|
Další výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Blood-based biomarkers
Časové okno: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
|
Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Castro JI, Valencia Llano CH, Tenorio DL, Saavedra M, Zapata P, Navia-Porras DP, Delgado-Ospina J, Chaur MN, Hernandez JHM, Grande-Tovar CD. Biocompatibility Assessment of Polylactic Acid (PLA) and Nanobioglass (n-BG) Nanocomposites for Biomedical Applications. Molecules. 2022 Jun 6;27(11):3640. doi: 10.3390/molecules27113640.
- 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.
- Mondal B, Choudhury S, Banerjee R, Roy A, Chatterjee K, Basu P, Singh R, Halder S, Shubham S, Baker SN, Baker MR, Kumar H. Effects of non-invasive vagus nerve stimulation on clinical symptoms and molecular biomarkers in Parkinson's disease. Front Aging Neurosci. 2024 Feb 7;15:1331575. doi: 10.3389/fnagi.2023.1331575. eCollection 2023.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
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První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2025.519
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