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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
VeNS device
Sham VeNS device
Sponsored by
Neurovalens Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • RD Gardi Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active

Sham

Arm Description

Outcomes

Primary Outcome Measures

Unified Parkinson's disease Rating Scale (UPDRS)
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).

Secondary Outcome Measures

Berg Balance Scale (BBS)
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.
Range of motion (ROM)
Range of motion is the available amount of movement of a joint. ROM will be obtained using a universal goniometer and standard protocol.
Muscle Strength
Muscle strength will be measured using the Micro FET 2 hand held dynamometer.
Assessment of hand-eye coordination
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.
Assessment of spatial memory
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
Assessment of verbal memory
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.
Auditory and visual reaction time
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).
Estimation of dopamine
Dopamine levels will be assessed using General Dopamine (DA) ELISA Kit.
Estimation of Gamma-Aminobutyric Acid (GABA)
GABA ELISA Kit will be used to estimate GABA levels
Assessment of quality of life
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.
Flexibility
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.
Assessment of radiological images
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
Assessment of neuronal loss
Diameter, area, volume, myelin disruption, gliosis ad=nd connectivity of the neuron will be measured to assess neuronal loss

Full Information

First Posted
June 11, 2020
Last Updated
April 26, 2023
Sponsor
Neurovalens Ltd.
Collaborators
R D Gardi Medical College, Ujjain
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1. Study Identification

Unique Protocol Identification Number
NCT04450550
Brief Title
Electrical Vestibular Nerve Stimulation (VeNS) in the Management of Parkinson's Disease
Official Title
Electrical Vestibular Neve Stimulation(VeNS) in the Management of Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurovalens Ltd.
Collaborators
R D Gardi Medical College, Ujjain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Active Comparator
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
VeNS device
Intervention Description
VeNS treatment
Intervention Type
Device
Intervention Name(s)
Sham VeNS device
Intervention Description
Sham treatment of VeNS
Primary Outcome Measure Information:
Title
Unified Parkinson's disease Rating Scale (UPDRS)
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Berg Balance Scale (BBS)
Description
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.
Time Frame
12 weeks
Title
Range of motion (ROM)
Description
Range of motion is the available amount of movement of a joint. ROM will be obtained using a universal goniometer and standard protocol.
Time Frame
12 weeks
Title
Muscle Strength
Description
Muscle strength will be measured using the Micro FET 2 hand held dynamometer.
Time Frame
12 weeks
Title
Assessment of hand-eye coordination
Description
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.
Time Frame
12 weeks
Title
Assessment of spatial memory
Description
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
Time Frame
12 weeks
Title
Assessment of verbal memory
Description
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.
Time Frame
12 weeks
Title
Auditory and visual reaction time
Description
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).
Time Frame
12 weeks
Title
Estimation of dopamine
Description
Dopamine levels will be assessed using General Dopamine (DA) ELISA Kit.
Time Frame
12 weeks
Title
Estimation of Gamma-Aminobutyric Acid (GABA)
Description
GABA ELISA Kit will be used to estimate GABA levels
Time Frame
12 weeks
Title
Assessment of quality of life
Description
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.
Time Frame
12 weeks
Title
Flexibility
Description
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.
Time Frame
12 weeks
Title
Assessment of radiological images
Description
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
Time Frame
12 weeks
Title
Assessment of neuronal loss
Description
Diameter, area, volume, myelin disruption, gliosis ad=nd connectivity of the neuron will be measured to assess neuronal loss
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sai Sailesh Kumar Goothy
Organizational Affiliation
RD Gardi Medical College, Ujjain
Official's Role
Principal Investigator
Facility Information:
Facility Name
RD Gardi Medical College
City
Ujjain
State/Province
Madhya Pradesh
ZIP/Postal Code
456001
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
36209355
Citation
Kumar Goothy SS, Gawarikar S, Choudhary A, Govind PG, Purohit M, Pathak A, Chouhan RS, Ali Z, Tiwari M, Khanderao MV. Effectiveness of electrical vestibular nerve stimulation on the range of motion in patients with Parkinson's disease. J Basic Clin Physiol Pharmacol. 2022 Oct 10. doi: 10.1515/jbcpp-2022-0138. Online ahead of print.
Results Reference
derived
PubMed Identifier
36103719
Citation
Kumar Goothy SS, Gawarikar S, Choudhary A, Gajanan Govind P, Purohit M, Pathak A, Chouhan RS, Vijay Khanderao M. Effectiveness of electrical vestibular nerve stimulation as adjunctive therapy to improve the cognitive functions in patients with Parkinson's disease. J Basic Clin Physiol Pharmacol. 2022 Sep 16;34(1):77-82. doi: 10.1515/jbcpp-2022-0066. eCollection 2023 Jan 1.
Results Reference
derived

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

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