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Completed

NCT Number: NCT02703844

Vestibular Stimulation in Parkinson's Disease

The purpose of this study is to determine whether caloric vestibular stimulation improves symptoms of Parkinson's Disease.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kent

Canterbury, Kent, CT2 7NP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caloric Vestibular Stimulation

Device

Stimulation of the vestibular nerves

Sham Caloric Vestibular Stimulation

Device

Sham stimulation of the vestibular nerves

Other names: Placebo

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Kent

Other

Registry information

Official study title

Caloric Vestibular Stimulation in Parkinson's Disease

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 9, 2016
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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