Electrical Vestibular Nerve Stimulation (VeNS) in the Management of Parkinson's Disease
Electrical Vestibular Neve Stimulation(VeNS) in the Management of Parkinson's Disease
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2020
CompletedFirst Posted
Study publicly available on registry
June 29, 2020
CompletedStudy Start
First participant enrolled
July 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedApril 27, 2023
April 1, 2023
1.3 years
June 11, 2020
April 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (13)
Berg Balance Scale (BBS)
12 weeks
Range of motion (ROM)
12 weeks
Muscle Strength
12 weeks
Assessment of hand-eye coordination
12 weeks
Assessment of spatial memory
12 weeks
- +8 more secondary outcomes
Study Arms (2)
Active
ACTIVE COMPARATORSham
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neurovalens Ltd.lead
- R D Gardi Medical College, Ujjaincollaborator
Study Sites (1)
RD Gardi Medical College
Ujjain, Madhya Pradesh, 456001, India
Related Publications (2)
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.
PMID: 36209355DERIVEDKumar 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.
PMID: 36103719DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sai Sailesh Kumar Goothy
RD Gardi Medical College, Ujjain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2020
First Posted
June 29, 2020
Study Start
July 26, 2021
Primary Completion
November 1, 2022
Study Completion
November 1, 2022
Last Updated
April 27, 2023
Record last verified: 2023-04