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

April 26, 2023 updated by: Neurovalens Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Madhya Pradesh
      • Ujjain, Madhya Pradesh, India, 456001
        • RD Gardi Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active
Device: VeNS device
VeNS treatment
Sham Comparator: Sham
Device: Sham VeNS device
Sham treatment of VeNS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unified Parkinson's disease Rating Scale (UPDRS)
Time Frame: 12 weeks
The UPDRS has been the most used Parkinsons disease scale. It is a 42 item questionnaire grouped into four subscales. A score of 199 on the UPDRS scale represents the worst (total disability) with a score of zero representing (no disability).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale (BBS)
Time Frame: 12 weeks
The 14 item scale is scored by the assessor. Postural stability will be assessed using the Berg balance scale. It assesses the ability of the individual to balance during a series of pre-determined tasks safely. he BBS is a qualitative measure that assesses balance via performing functional activities such as reaching, bending, transferring, and standing that incorporates most components of postural control: sitting and transferring safely between chairs; standing with feet apart, feet together, in single-leg stance, and feet in the tandem Romberg position with eyes open or closed; reaching and stooping down to pick something off the floor. Each item is scored along a 5-point scale, ranging from 0 to 4, each grade with well established criteria. Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56.
12 weeks
Range of motion (ROM)
Time Frame: 12 weeks
Range of motion is the available amount of movement of a joint. ROM will be obtained using a universal goniometer and standard protocol.
12 weeks
Muscle Strength
Time Frame: 12 weeks
Muscle strength will be measured using the Micro FET 2 hand held dynamometer.
12 weeks
Assessment of hand-eye coordination
Time Frame: 12 weeks
100 pin dexterity test will be performed to assess the speed of coordinated movements. The test requires smooth plastic pad containing fine pierceable100 holes in it and 100 push pins. This set is provided to each participant and is assigned with a task to pin all 100 push pins to the pad. The time required to complete the task will be recorded using a stopwatch. The value will be expressed in seconds.
12 weeks
Assessment of spatial memory
Time Frame: 12 weeks
20 power point slides presentation will be prepared and projected using a liquid crystal display (LCD) on the screen. Each slide consists of a simple line diagram which is easy to reproduce. Diagrams which could be verbally described like a square, circle, rectangle and pyramid will not included for testing. After showing all the 20 slides, a mathematical problem (e.g., 8-7+3-2+16+12-1+7) will be projected on the screen and asked to solve the problem. Later the participants will be asked to re-call all the 20 slides projected and draw on a paper within a minute. The correct answer are given a score as" 1", and an incorrect answer will be scored as" 0". Different sets of drawings will be used during pre and post assessments
12 weeks
Assessment of verbal memory
Time Frame: 12 weeks
20 power point slides will be prepared and projected using liquid crystal display (LCD) on the screen. Each slide consists of a three letter word like for example ZOL. After showing all the 20 slides, a mathematical problem (e.g., 9-4+3- 1+22+14-1+3) will be projected on the screen and asked to solve the problem. Later the participants are asked to recall all the 20 slides projected and recollect and present the same on a paper within a minute. The correct answer will be given a score as" 1", and an incorrect answer is scored as" 0". Different sets of drawings will be used during pre and post assessments.
12 weeks
Auditory and visual reaction time
Time Frame: 12 weeks
Reaction time (RT) apparatus used in the study to record auditory and visual RT was purchased from Anand Agencies, Pune. The RT apparatus presents two auditory (high and low pitch sounds) and two visual stimuli (red and green light).
12 weeks
Estimation of dopamine
Time Frame: 12 weeks
Dopamine levels will be assessed using General Dopamine (DA) ELISA Kit.
12 weeks
Estimation of Gamma-Aminobutyric Acid (GABA)
Time Frame: 12 weeks
GABA ELISA Kit will be used to estimate GABA levels
12 weeks
Assessment of quality of life
Time Frame: 12 weeks
The World Health Organization Quality of Life (WHO-QOL BREF) instrument is a self-administered questionnaire which consists of 26 questions to assess four domains that is physical health, psychological status, social relationships and environment. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Mean scores are then multiplied by 4 in order to make domain scores comparable.
12 weeks
Flexibility
Time Frame: 12 weeks
Flexibility is the ability of soft tissue structures, such as muscle, tendon, and connective tissue, to elongate through the available range of joint motion. Flexibility measurements will be obtained using a universal goniometer and standard protocol.
12 weeks
Assessment of radiological images
Time Frame: 12 weeks
MRIs of the cortex, basal ganglia, cerebellum, thalamus, hypothalamus, limbic system and glial cells will be used to assess neurological changes through radiological image data
12 weeks
Assessment of neuronal loss
Time Frame: 12 weeks
Diameter, area, volume, myelin disruption, gliosis ad=nd connectivity of the neuron will be measured to assess neuronal loss
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurovalens Ltd.

Collaborators

R D Gardi Medical College, Ujjain

Investigators

  • Principal Investigator: Sai Sailesh Kumar Goothy, RD Gardi Medical College, Ujjain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2021

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

November 1, 2022

Study Registration Dates

First Submitted

June 11, 2020

First Submitted That Met QC Criteria

June 26, 2020

First Posted (Actual)

June 29, 2020

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVSPD001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on VeNS device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe