Vestibular Stimulation in Parkinson's Disease

Not Applicable

Completed

Interventions: Device: Sham Caloric Vestibular Stimulation
Device: Caloric Vestibular Stimulation

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

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Sham Caloric Vestibular Stimulation	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.
Active	Caloric Vestibular Stimulation	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Nonmotor Symptom Severity Scale (NMSS)	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

Name	Time	Method
Change From Baseline in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III: Motor Examination	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
Change From Baseline in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II: Motor Aspects of Experiences of Daily Living	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