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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04450550
• Other study ID #: IVSPD001
• Status: Completed
• Phase: N/A
• Start date: July 26, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: April 2023
• Source: Neurovalens Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• VeNS device
VeNS treatment
• Sham VeNS device
Sham treatment of VeNS

Locations

Country	Name	City	State
India	RD Gardi Medical College	Ujjain	Madhya Pradesh

Sponsors (2)

Lead Sponsor	Collaborator
Neurovalens Ltd.	R D Gardi Medical College, Ujjain

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	Muscle Strength	Muscle strength will be measured using the Micro FET 2 hand held dynamometer.	12 weeks
Secondary	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.	12 weeks
Secondary	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	12 weeks
Secondary	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.	12 weeks
Secondary	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).	12 weeks
Secondary	Estimation of dopamine	Dopamine levels will be assessed using General Dopamine (DA) ELISA Kit.	12 weeks
Secondary	Estimation of Gamma-Aminobutyric Acid (GABA)	GABA ELISA Kit will be used to estimate GABA levels	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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	12 weeks
Secondary	Assessment of neuronal loss	Diameter, area, volume, myelin disruption, gliosis ad=nd connectivity of the neuron will be measured to assess neuronal loss	12 weeks