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Non-invasive Vagus Nerve Stimulation for Parkinson's Disease (VNS)

2 november 2026 bijgewerkt door: Vincent Mok, Chinese University of Hong Kong

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Idiopathic PD as defined by the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria

  2. Age 40 - 75 years old

  3. 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

  4. Availability of a caregiver at home

  5. Cantonese speaker

Exclusion Criteria:

  1. Patients with atypical parkinsonism (e.g., multiple system atrophy, progressive supranuclear palsy, dementia with Lewy Bodies)
  2. PD with dementia
  3. PD patients with DBS in-situ
  4. Severe PD with a Hoehn and Yahr staging of 4 or above
  5. 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)
  6. Cardiac pacemaker in-situ

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: conventional VNS

Parkinson Disease
Apparaat: cVNS

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.
Actieve vergelijker: exploratory VNS
Apparaat: eVNS

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.
Sham-vergelijker: sham VNS
Apparaat: sVNS

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"

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change of gait
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Change in mood
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change of blood pressure
Tijdsspanne: 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
Safety measures- record of adverse event and serious adverse event
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Tijdsspanne
Blood-based biomarkers
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Chinese University of Hong Kong

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

20 november 2026

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

30 juni 2028

Studieregistratiedata

Eerst ingediend

22 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 oktober 2026

Eerst geplaatst (Werkelijk)

2 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2025.519

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

only IPD used in the results publication will be shared

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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