Electrical Vestibular Nerve Stimulation (VeNS) in the Management of Parkinson's Disease
NCT ID: NCT04450550
Last Updated: 2023-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2021-07-26
2022-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of Noninvasive Vagus Stimulation for Upper Extremity in Parkinson's Disease
NCT05456451
The Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Anxiety in PD
NCT05950347
A Randomized Double-Blind Active-Controlled Crossover Trial of Respiratory-Gated Versus Non-Gated Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Motor and Non-Motor Symptoms in Parkinson's Disease
NCT06642454
Focal Muscle Vibration in Parkinson's Disease
NCT06278623
Effects of Vagal Nerve Stimulation on Leg Muscle Activity and Posture in Parkinson's Disease
NCT07226284
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active
VeNS device
VeNS treatment
Sham
Sham VeNS device
Sham treatment of VeNS
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
VeNS device
VeNS treatment
Sham VeNS device
Sham treatment of VeNS
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
R D Gardi Medical College, Ujjain
UNKNOWN
Neurovalens Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sai Sailesh Kumar Goothy
Role: PRINCIPAL_INVESTIGATOR
RD Gardi Medical College, Ujjain
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
RD Gardi Medical College
Ujjain, Madhya Pradesh, India
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IVSPD001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.