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Vestibular Stimulation in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02703844
Recruitment Status : Active, not recruiting
First Posted : March 9, 2016
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
University of Kent

Study Description
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Brief Summary:
The purpose of this study is to determine whether caloric vestibular stimulation improves symptoms of Parkinson's Disease.

Condition or disease Intervention/treatment Phase
Parkinson's Disease and Parkinsonism Device: Caloric Vestibular Stimulation Device: Sham Caloric Vestibular Stimulation Not Applicable

Detailed Description:
Parkinson's Disease (PD) is a nationwide public health problem, inflicting a complex constellation of physical and neuropsychiatric symptoms which are shown to progress with time. This research will investigate the potential of caloric vestibular stimulation (CVS), a non-invasive form of brain stimulation, as a treatment for individuals who suffer from Parkinson's Disease. Investigators will investigate whether core cognitive and physiological deficits are responsive to stimulation by comparing participants' performance on behavioral and physiological measures after baseline and either active or placebo stimulation phases with the aim of drawing initial insights into the application of CVS within this population. The study design is based on a single-case study that recently demonstrated durable, clinically meaningful gains in the motor and cognitive symptoms of PD.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Caloric Vestibular Stimulation in Parkinson's Disease
Study Start Date : March 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active
Participants will be receiving an active Caloric Vestibular Stimulation treatment for a duration of 12 weeks, 7 days a week, twice daily for 20 minutes.
 Device: Caloric Vestibular Stimulation
Stimulation of the vestibular nerves
Sham Comparator: Placebo

Participants will be receiving a Sham Caloric Vestibular Stimulation treatment for a duration of 12 weeks in the same manner as the active arm: 7 days a week, twice daily for 20 minutes.

Individuals allocated to this arm will be later crossed over, in unblinded fashion. to the active arm if the treatment shows evidence of efficacy and safety.

 Device: Sham Caloric Vestibular Stimulation
Sham stimulation of the vestibular nerves
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Unified Parkinson's Disease Rating Scale (UPDRS). questionnaire [ Time Frame: 16 weeks ]
    We expect changes mainly in the motor subscale.

  2. 2 Minute Walk behavioural measurement [ Time Frame: 16 weeks ]
    Distance walked by the patient in 2 minutes is measured.

  3. 10 Meter Walk behavioural measurement [ Time Frame: 16 weeks ]
    An average time of a normal-speed and fast-speed of gait on a distance of 10 meters taken three times is measured.

  4. Timed Up and Go behavioural measurement [ Time Frame: 16 weeks ]
    time taken to get up from a chair, walk 3 meters, go back and sit down is measured.

  5. Montreal Cognitive Assessment (MoCA) Questionnaire [ Time Frame: 16 weeks ]
    cognitive ability test

  6. EQ-5D-3L Questionnaire [ Time Frame: 16 weeks ]
    Activity of daily living scale

  7. Schwab and England Scale Questionnaire [ Time Frame: 16 weeks ]
    Health Questionnaire

  8. PD-39 Questionnaire [ Time Frame: 16 weeks ]
    Health-related Parkinson's Disease questionnaire

  9. Hospital Anxiety and Depression Scale Questionnaire [ Time Frame: 16 weeks ]
    depression and anxiety questionnaire

  10. Epworth Sleepiness Scale Questionnaire [ Time Frame: 16 weeks ]
  11. Fatigue Severity Scale Questionnaire [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. EEG/Event - Related Potentials abnormalities - Physiological measurement [ Time Frame: 16 weeks ]
    Assessment of any changes to P300 during ERPs and beta wave in a resting state.

  2. SPECT DaTSCAN - Physiological measurement [ Time Frame: 16 weeks ]
    Assessment of any changes in the concentration of dopamine within the central nervous system


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of Parkinson's Disease (as defined by the UK PDS Brain Bank Criteria) or atypical Parkinson's disease (aka Parkinsonism), comprising progressive supranuclear palsy, multiple system atropy and cortico-basal degeneration).
  • limitations to Activities of Daily Life (ADL, UPDRS subscale 2)
  • Capacity to consent to the study
  • good level of spoken English

Exclusion Criteria:

  • Diagnosis of induced Parkinson's or essential/dystonic tremor
  • Premorbid psychiatric history (including affective disorder, psychosis or deliberate self- harm)
  • Previous exposure to neurostimulation
  • Inner ear pathology
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703844


Locations
United Kingdom
University of Kent
Canterbury, Kent, United Kingdom, CT2 7NP
Sponsors and Collaborators
University of Kent
More Information
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Responsible Party: University of Kent
ClinicalTrials.gov Identifier: NCT02703844     History of Changes
Other Study ID Numbers: KENT/DW/PD/2016
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This has not been yet agreed upon.

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases