Vestibular Stimulation in Parkinson's Disease

NCT ID: NCT02703844

Last Updated: 2022-10-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-07-21

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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Active

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.

Group Type ACTIVE_COMPARATOR

Caloric Vestibular Stimulation

Intervention Type DEVICE

Stimulation of the vestibular nerves

Placebo

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.

Group Type SHAM_COMPARATOR

Sham Caloric Vestibular Stimulation

Intervention Type DEVICE

Sham stimulation of the vestibular nerves

Interventions

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Caloric Vestibular Stimulation

Stimulation of the vestibular nerves

Intervention Type DEVICE

Sham Caloric Vestibular Stimulation

Sham stimulation of the vestibular nerves

Intervention Type DEVICE

Other Intervention Names

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Placebo

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicole Palmer

Role: STUDY_DIRECTOR

University of Kent (research ethics & governance lead)

Locations

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University of Kent

Canterbury, Kent, United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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KENT/DW/PD/2016

Identifier Type: -

Identifier Source: org_study_id

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