Parkinson DiseaseNCT04450550
Electrical Vestibular Nerve Stimulation (VeNS) in the Management of Parkinson's Disease
A study testing VeNS device in people with Parkinson Disease, run by Neurovalens Ltd. at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- VeNS device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 26 Jul 2021to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrical Vestibular Neve Stimulation(VeNS) in the Management of Parkinson's Disease
Parkinson's disease burdens an increasing number of elderly populations in the country.
Parkinson disease is a chronic, progressive neurodegenerative disorder, affects approximately
Read more
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.
- Conditions
- Parkinson Disease
- Being tested
- VeNS device, Sham VeNS device
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeNS deviceDevice
VeNS treatment
Sham VeNS deviceDevice
Sham treatment of VeNS
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Not described Receives: Device: VeNS device |
| Sham | Sham comparator | Not described Receives: Device: Sham VeNS device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (13)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Muscle Strength
Muscle strength will be measured using the Micro FET 2 hand held dynamometer.
Measured: 12 weeks
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.
Measured: 12 weeks
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
Measured: 12 weeks
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.
Measured: 12 weeks
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).
Measured: 12 weeks
Estimation of dopamine
Dopamine levels will be assessed using General Dopamine (DA) ELISA Kit.
Measured: 12 weeks
Estimation of Gamma-Aminobutyric Acid (GABA)
GABA ELISA Kit will be used to estimate GABA levels
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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
Measured: 12 weeks
Assessment of neuronal loss
Diameter, area, volume, myelin disruption, gliosis ad=nd connectivity of the neuron will be measured to assess neuronal loss
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start26 Jul 2021
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurovalens Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- R D Gardi Medical College, Ujjain
- Responsible party
- Sponsor
- Investigators
- Sai Sailesh Kumar Goothy, Principal investigator, RD Gardi Medical College, Ujjain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450550
- Sponsor's protocol ID
- IVSPD001
- Status last verified
- Apr 2023
- First submitted
- 11 Jun 2020
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36209355Kumar 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.
PubMed 36103719
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Vestibular Neve Stimulation(VeNS) in the Management of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04450550
- Acronym / sponsor ID
- IVSPD001
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Neurovalens Ltd.Industry (pharma, biotech, devices)
- Collaborators
- R D Gardi Medical College, Ujjain
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: VeNS device |
| Sham | Sham comparator | Device: Sham VeNS device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VeNS deviceVeNS treatment | Device | Active |
| Sham VeNS deviceSham treatment of VeNS | Device | Sham |
Primary outcome
Unified Parkinson's disease Rating Scale (UPDRS)
Time frame: 12 weeks
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).
13 secondary outcomes
Berg Balance Scale (BBS)
Time frame: 12 weeks
Range of motion (ROM)
Time frame: 12 weeks
Muscle Strength
Time frame: 12 weeks
Assessment of hand-eye coordination
Time frame: 12 weeks
Assessment of spatial memory
Time frame: 12 weeks
Assessment of verbal memory
Time frame: 12 weeks
Auditory and visual reaction time
Time frame: 12 weeks
Estimation of dopamine
Time frame: 12 weeks
Estimation of Gamma-Aminobutyric Acid (GABA)
Time frame: 12 weeks
Assessment of quality of life
Time frame: 12 weeks
Flexibility
Time frame: 12 weeks
Assessment of radiological images
Time frame: 12 weeks
Assessment of neuronal loss
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Derived from this study: PubMed 36209355Kumar 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.
- Derived from this study: PubMed 36103719Kumar 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.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sai Sailesh Kumar Goothy principal investigator
RD Gardi Medical College, Ujjain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VeNS device in people with Parkinson Disease, run by Neurovalens Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson's disease Rating Scale (UPDRS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04450550, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.