Clinical trial NCT02703844: Vestibular Stimulation in Parkinson's Disease
Official title: Caloric Vestibular Stimulation in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: University of Kent
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in the Nonmotor Symptom Severity Scale (NMSS)
timeFrame: Change at end of treatment (week 12) relative to the average of two baseline visits
Secondary outcomes:
measure: Change From Baseline in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II: Motor Aspects of Experiences of Daily Living
timeFrame: Change at end of treatment (week 12) relative to baseline average
measure: Change From Baseline in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III: Motor Examination
timeFrame: Change at end of treatment (week 12) relative to baseline average
Other outcomes:
measure: Change From Baseline in the Montreal Cognitive Assessment
timeFrame: Change at one-month post-treatment follow-up (week 17) relative to baseline average
measure: Change From Baseline in the Epworth Sleepiness Scale
timeFrame: Change at one-month post-treatment follow-up (week 17) relative to baseline average
measure: Change From Baseline in the Modified Schwab & England
timeFrame: Change at one-month post-treatment follow-up (week 17) relative to baseline average
measure: Change From Baseline in the 2 Minute Walk
timeFrame: Change at one-month post-treatment follow-up (week 17) relative to baseline average
measure: Change From Baseline in the 10 Meter Walk
timeFrame: Change at one-month post-treatment follow-up (week 17) relative to baseline average
measure: Change From Baseline in the Timed Up and Go (TUG)
timeFrame: Change at one-month post-treatment follow-up (week 17) relative to baseline average
measure: Change From Baseline in the Fatigue Severity Scale
timeFrame: Change at one-month post-treatment follow-up (week 17) relative to baseline average
measure: Change From Baseline in the EuroQol 5D
timeFrame: Change at one-month post-treatment follow-up (week 17) relative to baseline average
measure: Change From Baseline in the SF-12 Health Survey
timeFrame: Change at one-month post-treatment follow-up (week 17) relative to baseline average
measure: Change From Baseline in the Hospital Anxiety and Depression Scale
timeFrame: Change at one-month post-treatment follow-up (week 17) relative to baseline average
measure: EEG/Event - Related Potentials Abnormalities - Physiological Measurement
timeFrame: Change at end of treatment (week 12) relative to baseline
Locations:
city: Canterbury
country: United Kingdom
facility: University of Kent
state: Kent
Study officials:
affiliation: University of Kent (research ethics & governance lead)
name: Nicole Palmer
role: STUDY_DIRECTOR
References: