Vestibular Stimulation in Parkinson's Disease

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

Detailed Description
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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.

Official Title
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Caloric Vestibular Stimulation in Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: Caloric Vestibular Stimulation
* Device: Sham Caloric Vestibular Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>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<br>* Stimulation of the vestibular nerves<br>|
| Sham Comparator: Placebo<br>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<br>* Sham stimulation of the vestibular nerves<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Nonmotor Symptom Severity Scale (NMSS) | 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 | Change at end of treatment (week 12) relative to the average of two baseline visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II: Motor Aspects of Experiences of Daily Living | 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 | Change at end of treatment (week 12) relative to baseline average | 
| Change From Baseline in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III: Motor Examination | 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 | Change at end of treatment (week 12) relative to baseline average |