Vestibular Stimulation in Parkinson's Disease

University of Kent46 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Parkinson's Disease

Interventions

Caloric Vestibular StimulationDEVICE

Stimulation of the vestibular nerves

Sham Caloric Vestibular StimulationDEVICE

Sham stimulation of the vestibular nerves

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kent

Canterbury, Kent, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: Change at end of treatment (week 12) relative to the average of two baseline visits

Secondary Outcomes

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

Time frame: 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

Time frame: Change at end of treatment (week 12) relative to baseline average

Data from ClinicalTrials.gov

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