NCT04450550

Electrical Vestibular Nerve Stimulation (VeNS) in the Management of Parkinson's Disease

Completed NA Last updated 27 April 2023

What this trial tests

NA trial testing VeNS device in Parkinson Disease in 60 participants. Completed in 1 November 2022.

Timeline

26 July 2021

Primary endpoint
1 November 2022

1 November 2022

Quick facts

Lead sponsor	Neurovalens Ltd.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	26 July 2021
Primary completion	1 November 2022
Estimated completion	1 November 2022
Sites	1 location across India

Drugs / interventions tested

• VeNS device
• Sham VeNS device

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

Neurovalens Ltd.

Who can join

18 and older, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Parkinson's disease burdens an increasing number of elderly populations in the country.

Parkinson disease is a chronic, progressive neurodegenerative disorder, affects approximately

1% of the population by the age of 65 years and 4% to 5% of the population by the age of 85 years. Mild cognitive impairment in Parkinson's disease leads to Parkinson's disease dementia (PDD) for which currently there is no drug therapy. The existing treatments for PD were associated with side effects and does not offer complete cure. Hence there is a need of alternative therapy which can prevent or delay the onset of PD with less or no side effects. Vestibular stimulation is known to modulate cognitive processing, enhance learning and spatial memory.

Vestibular dysfunction is present in PD patients. So long term vestibular stimulation may be effective in enhancing cognition by reducing the cognitive, neurodegenerative, neuroinflammatory changes and behavioral deficits observed as predictors of Mild Cognitive Impairment in Parkinson's disease Dementia. In this project, the plan is to administer electric vestibular nerve stimulation to PD patients which might be effective and ideal treatment with minimum or no side effects in the management of Parkinson's disease.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treatment of Parkinson's Disease with Cognitive Impairment: Current Approaches and Future Directions.
   Sun C, Armstrong MJ. · · 2021 · cited 50× · PMID 33920698 · DOI 10.3390/bs11040054
2. Effectiveness of electrical vestibular nerve stimulation as adjunctive therapy to improve the cognitive functions in patients with Parkinson's disease.
   Kumar Goothy SS, Gawarikar S, Choudhary A, Gajanan Govind P, et al · · 2023 · cited 2× · PMID 36103719 · DOI 10.1515/jbcpp-2022-0066
3. Effectiveness of electrical vestibular nerve stimulation on the range of motion in patients with Parkinson's disease.
   Kumar Goothy SS, Gawarikar S, Choudhary A, Govind PG, et al · · 2023 · PMID 36209355 · DOI 10.1515/jbcpp-2022-0138