Vestibular Stimulation in Parkinson's Disease

University of Kent

Status: Completed

Conditions: Parkinson's Disease

Treatments: Device: Sham Caloric Vestibular Stimulation; Device: Caloric Vestibular Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02703844

KENT/DW/PD/2016

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups

Active

Active Comparator group

Description:

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.

Treatment:

Device: Caloric Vestibular Stimulation

Placebo

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Caloric Vestibular Stimulation