Vestibular Stimulation in Parkinson's Disease

Caloric Vestibular Stimulation in Parkinson's Disease

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

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: Caloric Vestibular Stimulation; Device: Sham Caloric Vestibular Stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Canterbury, Kent, United Kingdom, CT2 7NP
      • University of Kent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Device: Caloric Vestibular Stimulation; Stimulation of the vestibular nerves
SHAM_COMPARATOR: 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.	Device: Sham Caloric Vestibular Stimulation; Sham stimulation of the vestibular nerves; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change at end of treatment (week 12) relative to the average of two baseline visits

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Change at end of treatment (week 12) relative to baseline average

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Montreal Cognitive Assessment	rapid screening instrument for mild cognitive dysfunction, with a score range from zero to 30, with higher being closer to normal	Change at one-month post-treatment follow-up (week 17) relative to baseline average
Change From Baseline in the Epworth Sleepiness Scale	a brief measure that is commonly used to assess daytime sleepiness in PD and other disorders. Scores can range from 0 to 24. The higher the score, the higher that person's average daytime sleepiness	Change at one-month post-treatment follow-up (week 17) relative to baseline average
Change From Baseline in the Modified Schwab & England	clinical outcome assessment of an individual's ability to function in activities of daily living	Change at one-month post-treatment follow-up (week 17) relative to baseline average
Change From Baseline in the 2 Minute Walk	performance measure of walking ability and functional capacity	Change at one-month post-treatment follow-up (week 17) relative to baseline average
Change From Baseline in the 10 Meter Walk	performance measure used to assess walking speed	Change at one-month post-treatment follow-up (week 17) relative to baseline average
Change From Baseline in the Timed Up and Go (TUG)	measures gait and the probability of falls in adults	Change at one-month post-treatment follow-up (week 17) relative to baseline average
Change From Baseline in the Fatigue Severity Scale	questionnaire for evaluating the impact of fatigue. scores range from 9-63 with a higher score for greater fatigue.	Change at one-month post-treatment follow-up (week 17) relative to baseline average
Change From Baseline in the EuroQol 5D	questionnaire for use in clinical and economic appraisal and population health. scores range from 0-100 for each question with 0 being the worst and 100 being the best	Change at one-month post-treatment follow-up (week 17) relative to baseline average
Change From Baseline in the SF-12 Health Survey	self-reported outcome measure assessing the impact of health on an individual's everyday life. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning	Change at one-month post-treatment follow-up (week 17) relative to baseline average
Change From Baseline in the Hospital Anxiety and Depression Scale	self-rating scale developed to assess psychological distress. scores range between 0-21 with higher scores equaling more severe impairment	Change at one-month post-treatment follow-up (week 17) relative to baseline average
EEG/Event - Related Potentials Abnormalities - Physiological Measurement	Assessment of any changes to P300 during ERPs and beta wave in a resting state.	Change at end of treatment (week 12) relative to baseline

Collaborators and Investigators

• Sponsor: University of Kent
• Investigators: Study Director: Nicole Palmer, University of Kent (research ethics & governance lead)

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (ACTUAL): October 9, 2017
• Study Completion (ACTUAL): July 21, 2018

Study Registration Dates

• First Submitted: February 26, 2016
• First Submitted That Met QC Criteria: March 8, 2016
• First Posted (ESTIMATE): March 9, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: KENT/DW/PD/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all clinical outcome measures have been made available.
• IPD Sharing Time Frame: The data is available in an online repository.
• IPD Sharing Access Criteria: The data is provided in an open-access format.

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes