Clinical trial NCT04450550: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Neurovalens Ltd.
Sponsor class: INDUSTRY
Collaborators: name: R D Gardi Medical College, Ujjain
First posted: 2020-06-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Unified Parkinson's disease Rating Scale (UPDRS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: 12 weeks
measure: Range of motion (ROM)
timeFrame: 12 weeks
measure: Muscle Strength
timeFrame: 12 weeks
measure: Assessment of hand-eye coordination
timeFrame: 12 weeks
measure: Assessment of spatial memory
timeFrame: 12 weeks
measure: Assessment of verbal memory
timeFrame: 12 weeks
measure: Auditory and visual reaction time
timeFrame: 12 weeks
measure: Estimation of dopamine
timeFrame: 12 weeks
measure: Estimation of Gamma-Aminobutyric Acid (GABA)
timeFrame: 12 weeks
measure: Assessment of quality of life
timeFrame: 12 weeks
measure: Flexibility
timeFrame: 12 weeks
measure: Assessment of radiological images
timeFrame: 12 weeks
measure: Assessment of neuronal loss
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ujjain
country: India
facility: RD Gardi Medical College
state: Madhya Pradesh
Study officials:
affiliation: RD Gardi Medical College, Ujjain
name: Sai Sailesh Kumar Goothy
role: PRINCIPAL_INVESTIGATOR
References:
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;34(6):791-795. doi: 10.1515/jbcpp-2022-0138. eCollection 2023 Nov 1.
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.