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

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Neurovalens

Status

Completed

Conditions

Parkinson Disease

Treatments

Device: Sham VeNS device
Device: VeNS device

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT04450550
IVSPD001

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Fulfilled the Hoehn & Yahr Classification of Disability 79,80 stage 1-2
  • Ambulate with or without an assistive device for at least 50 feet
  • Were able to get up and down from the floor with minimal assistance or less and
  • Score of 24 or above on the Folstein Mini-Mental State Exam

Exclusion criteria

  • Decline in immune function such as pneumonia or systemic infection
  • Progressive degenerative disease besides PD
  • Spinal fusion or other orthopedic surgery in the past six months
  • Mental disease/psychosis such as dementia
  • Greater than minimal assistance required for gait and transfers
  • Inability to make regular time commitments to the scheduled intervention sessions
  • Experience with regular practice of any form of vestibular stimulation within the past year

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups

Active
Active Comparator group
Treatment:
Device: VeNS device
Sham
Sham Comparator group
Treatment:
Device: Sham VeNS device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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