<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04450550</url>
  </required_header>
  <id_info>
    <org_study_id>IVSPD001</org_study_id>
    <nct_id>NCT04450550</nct_id>
  </id_info>
  <brief_title>Electrical Vestibular Nerve Stimulation (VeNS) in the Management of Parkinson's Disease</brief_title>
  <official_title>Electrical Vestibular Neve Stimulation(VeNS) in the Management of Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neurovalens Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>R D Gardi Medical College, Ujjain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Neurovalens Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parkinson's disease burdens an increasing number of elderly populations in the country.&#xD;
&#xD;
      Parkinson disease is a chronic, progressive neurodegenerative disorder, affects approximately&#xD;
&#xD;
      1% of the population by the age of 65 years and 4% to 5% of the population by the age of 85&#xD;
      years. Mild cognitive impairment in Parkinson's disease leads to Parkinson's disease dementia&#xD;
      (PDD) for which currently there is no drug therapy. The existing treatments for PD were&#xD;
      associated with side effects and does not offer complete cure. Hence there is a need of&#xD;
      alternative therapy which can prevent or delay the onset of PD with less or no side effects.&#xD;
      Vestibular stimulation is known to modulate cognitive processing, enhance learning and&#xD;
      spatial memory.&#xD;
&#xD;
      Vestibular dysfunction is present in PD patients. So long term vestibular stimulation may be&#xD;
      effective in enhancing cognition by reducing the cognitive, neurodegenerative,&#xD;
      neuroinflammatory changes and behavioral deficits observed as predictors of Mild Cognitive&#xD;
      Impairment in Parkinson's disease Dementia. In this project, the plan is to administer&#xD;
      electric vestibular nerve stimulation to PD patients which might be effective and ideal&#xD;
      treatment with minimum or no side effects in the management of Parkinson's disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 26, 2021</start_date>
  <completion_date type="Actual">November 1, 2022</completion_date>
  <primary_completion_date type="Actual">November 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Unified Parkinson's disease Rating Scale (UPDRS)</measure>
    <time_frame>12 weeks</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale (BBS)</measure>
    <time_frame>12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion (ROM)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Range of motion is the available amount of movement of a joint. ROM will be obtained using a universal goniometer and standard protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle Strength</measure>
    <time_frame>12 weeks</time_frame>
    <description>Muscle strength will be measured using the Micro FET 2 hand held dynamometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of hand-eye coordination</measure>
    <time_frame>12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of spatial memory</measure>
    <time_frame>12 weeks</time_frame>
    <description>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&quot; 1&quot;, and an incorrect answer will be scored as&quot; 0&quot;. Different sets of drawings will be used during pre and post assessments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of verbal memory</measure>
    <time_frame>12 weeks</time_frame>
    <description>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&quot; 1&quot;, and an incorrect answer is scored as&quot; 0&quot;. Different sets of drawings will be used during pre and post assessments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Auditory and visual reaction time</measure>
    <time_frame>12 weeks</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimation of dopamine</measure>
    <time_frame>12 weeks</time_frame>
    <description>Dopamine levels will be assessed using General Dopamine (DA) ELISA Kit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimation of Gamma-Aminobutyric Acid (GABA)</measure>
    <time_frame>12 weeks</time_frame>
    <description>GABA ELISA Kit will be used to estimate GABA levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of quality of life</measure>
    <time_frame>12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flexibility</measure>
    <time_frame>12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of radiological images</measure>
    <time_frame>12 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of neuronal loss</measure>
    <time_frame>12 weeks</time_frame>
    <description>Diameter, area, volume, myelin disruption, gliosis ad=nd connectivity of the neuron will be measured to assess neuronal loss</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VeNS device</intervention_name>
    <description>VeNS treatment</description>
    <arm_group_label>Active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham VeNS device</intervention_name>
    <description>Sham treatment of VeNS</description>
    <arm_group_label>Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fulfilled the Hoehn &amp; Yahr Classification of Disability 79,80 stage 1-2&#xD;
&#xD;
          -  Ambulate with or without an assistive device for at least 50 feet&#xD;
&#xD;
          -  Were able to get up and down from the floor with minimal assistance or less and&#xD;
&#xD;
          -  Score of 24 or above on the Folstein Mini-Mental State Exam&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Decline in immune function such as pneumonia or systemic infection&#xD;
&#xD;
          -  Progressive degenerative disease besides PD&#xD;
&#xD;
          -  Spinal fusion or other orthopedic surgery in the past six months&#xD;
&#xD;
          -  Mental disease/psychosis such as dementia&#xD;
&#xD;
          -  Greater than minimal assistance required for gait and transfers&#xD;
&#xD;
          -  Inability to make regular time commitments to the scheduled intervention sessions&#xD;
&#xD;
          -  Experience with regular practice of any form of vestibular stimulation within the past&#xD;
             year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sai Sailesh Kumar Goothy</last_name>
    <role>Principal Investigator</role>
    <affiliation>RD Gardi Medical College, Ujjain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>RD Gardi Medical College</name>
      <address>
        <city>Ujjain</city>
        <state>Madhya Pradesh</state>
        <zip>456001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>April 26, 2023</last_update_submitted>
  <last_update_submitted_qc>April 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04450550
org study id: IVSPD001
nct id: NCT04450550
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Unified Parkinson's disease Rating Scale (UPDRS)
time frame: 12 weeks
description: 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).
measure: Berg Balance Scale (BBS)
time frame: 12 weeks
description: 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.
measure: Range of motion (ROM)
time frame: 12 weeks
description: Range of motion is the available amount of movement of a joint. ROM will be obtained using a universal goniometer and standard protocol.
measure: Muscle Strength
time frame: 12 weeks
description: Muscle strength will be measured using the Micro FET 2 hand held dynamometer.
measure: Assessment of hand-eye coordination
time frame: 12 weeks
description: 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.
measure: Assessment of spatial memory
time frame: 12 weeks
description: 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
measure: Assessment of verbal memory
time frame: 12 weeks
description: 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.
measure: Auditory and visual reaction time
time frame: 12 weeks
description: 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).
measure: Estimation of dopamine
time frame: 12 weeks
description: Dopamine levels will be assessed using General Dopamine (DA) ELISA Kit.
measure: Estimation of Gamma-Aminobutyric Acid (GABA)
time frame: 12 weeks
description: GABA ELISA Kit will be used to estimate GABA levels
measure: Assessment of quality of life
time frame: 12 weeks
description: 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.
measure: Flexibility
time frame: 12 weeks
description: 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.
measure: Assessment of radiological images
time frame: 12 weeks
description: 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
measure: Assessment of neuronal loss
time frame: 12 weeks
description: Diameter, area, volume, myelin disruption, gliosis ad=nd connectivity of the neuron will be measured to assess neuronal loss
arm group label: Active
arm group type: Active Comparator
arm group label: Sham
arm group type: Sham Comparator
intervention type: Device
intervention name: VeNS device
description: VeNS treatment
arm group label: Active
intervention type: Device
intervention name: Sham VeNS device
description: Sham treatment of VeNS
arm group label: Sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sai Sailesh Kumar Goothy
role: Principal Investigator
affiliation: RD Gardi Medical College, Ujjain
facility: 
country: India
responsible party type: Sponsor
mesh term: Parkinson Disease