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Vestibular Stimulation in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02703844
Recruitment Status : Completed
First Posted : March 9, 2016
Results First Posted : October 31, 2022
Last Update Posted : October 31, 2022
Sponsor:
Information provided by (Responsible Party):
University of Kent

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 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 nonmotor symptoms of PD.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 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
Actual Primary Completion Date : October 9, 2017
Actual Study Completion Date : July 21, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active
Participants will be receiving an active Caloric Vestibular Stimulation treatment for a duration of 8 weeks, 7 days a week, twice daily for 19 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 8 weeks in the same manner as the active arm: 7 days a week, twice daily for 19 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




Primary Outcome Measures :
  1. Change From Baseline in the Nonmotor Symptom Severity Scale (NMSS) [ Time Frame: Change at end of treatment (week 12) relative to the average of two baseline visits ]
    The NMSS is a 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. Score range of 0-360, with 0 being no symptom burden


Secondary Outcome Measures :
  1. Change From Baseline in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II: Motor Aspects of Experiences of Daily Living [ Time Frame: Change at end of treatment (week 12) relative to baseline average ]
    The MDS-UPDRS Part II is a 13-item patient-reported assessment of activities of motor aspects of experiences of daily living. Scores range between 0-52, with the higher score indicating greater impairment to activities of daily living

  2. Change From Baseline in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III: Motor Examination [ Time Frame: Change at end of treatment (week 12) relative to baseline average ]
    The MDS-UPDRS Part III is a 33-item assessment of motor function evaluated by a trained blinded rater. Scores range between 0-132 with higher scores indicating more severe motor symptoms


Other Outcome Measures:
  1. Change From Baseline in the Montreal Cognitive Assessment [ Time Frame: Change at one-month post-treatment follow-up (week 17) relative to baseline average ]
    rapid screening instrument for mild cognitive dysfunction, with a score range from zero to 30, with higher being closer to normal

  2. Change From Baseline in the Epworth Sleepiness Scale [ Time Frame: Change at one-month post-treatment follow-up (week 17) relative to baseline average ]
    a brief measure that is commonly used to assess daytime sleepiness in PD and other disorders. Scores can range from 0 to 24. The higher the score, the higher that person's average daytime sleepiness

  3. Change From Baseline in the Modified Schwab & England [ Time Frame: Change at one-month post-treatment follow-up (week 17) relative to baseline average ]
    clinical outcome assessment of an individual's ability to function in activities of daily living

  4. Change From Baseline in the 2 Minute Walk [ Time Frame: Change at one-month post-treatment follow-up (week 17) relative to baseline average ]
    performance measure of walking ability and functional capacity

  5. Change From Baseline in the 10 Meter Walk [ Time Frame: Change at one-month post-treatment follow-up (week 17) relative to baseline average ]
    performance measure used to assess walking speed

  6. Change From Baseline in the Timed Up and Go (TUG) [ Time Frame: Change at one-month post-treatment follow-up (week 17) relative to baseline average ]
    measures gait and the probability of falls in adults

  7. Change From Baseline in the Fatigue Severity Scale [ Time Frame: Change at one-month post-treatment follow-up (week 17) relative to baseline average ]
    questionnaire for evaluating the impact of fatigue. scores range from 9-63 with a higher score for greater fatigue.

  8. Change From Baseline in the EuroQol 5D [ Time Frame: Change at one-month post-treatment follow-up (week 17) relative to baseline average ]
    questionnaire for use in clinical and economic appraisal and population health. scores range from 0-100 for each question with 0 being the worst and 100 being the best

  9. Change From Baseline in the SF-12 Health Survey [ Time Frame: Change at one-month post-treatment follow-up (week 17) relative to baseline average ]
    self-reported outcome measure assessing the impact of health on an individual's everyday life. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning

  10. Change From Baseline in the Hospital Anxiety and Depression Scale [ Time Frame: Change at one-month post-treatment follow-up (week 17) relative to baseline average ]
    self-rating scale developed to assess psychological distress. scores range between 0-21 with higher scores equaling more severe impairment

  11. EEG/Event - Related Potentials Abnormalities - Physiological Measurement [ Time Frame: Change at end of treatment (week 12) relative to baseline ]
    Assessment of any changes to P300 during ERPs and beta wave in a resting state.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must be diagnosed with idiopathic Parkinson's Disease as defined by the UK PDS Brain Bank Criteria.
  • Participants must report limitations to Activities of Daily Life (ADL, UPDRS subscale 2)
  • Capacity to consent to the study
  • Motivated to comply with the protocol
  • An understanding of English sufficient to comply with the protocol
  • Spouse/ carer willing to support the participant throughout the study

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

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
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United Kingdom
University of Kent
Canterbury, Kent, United Kingdom, CT2 7NP
Sponsors and Collaborators
University of Kent
Investigators
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Study Director: Nicole Palmer University of Kent (research ethics & governance lead)
  Study Documents (Full-Text)

Documents provided by University of Kent:
Study Protocol  [PDF] July 25, 2018
Statistical Analysis Plan  [PDF] August 15, 2018

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Responsible Party: University of Kent
ClinicalTrials.gov Identifier: NCT02703844    
Other Study ID Numbers: KENT/DW/PD/2016
First Posted: March 9, 2016    Key Record Dates
Results First Posted: October 31, 2022
Last Update Posted: October 31, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all clinical outcome measures have been made available.
Time Frame: The data is available in an online repository.
Access Criteria: The data is provided in an open-access format.
URL: https://data.mendeley.com/datasets/m7ths6gdv9/1

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases