Vestibular Stimulation in Parkinson's Disease

NCT02703844 | Completed Results FDA Device

• 1 other identifier: KENT/DW/PD/2016
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change From Baseline in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II: Motor Aspects of Experiences 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

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

Other Outcomes (11)

• Change From Baseline in the Montreal Cognitive Assessment

  Change at one-month post-treatment follow-up (week 17) relative to baseline average

• Change From Baseline in the Epworth Sleepiness Scale

  Change at one-month post-treatment follow-up (week 17) relative to baseline average

• Change From Baseline in the Modified Schwab & England

  Change at one-month post-treatment follow-up (week 17) relative to baseline average

Study Arms (2)

Active

ACTIVE COMPARATOR

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

Placebo

SHAM COMPARATOR

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

Interventions

Caloric Vestibular Stimulation DEVICE

Stimulation of the vestibular nerves

Active

Sham Caloric Vestibular Stimulation DEVICE

Sham stimulation of the vestibular nerves

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kent: lead

Study Sites (1)

University of Kent

Canterbury, Kent, CT2 7NP, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: David Wilkinson
• Organization: University of Kent

d.t.wilkinson@kent.ac.uk

+44 (0)1227 824772

Study Officials

• Nicole Palmer

  University of Kent (research ethics & governance lead)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: March 9, 2016
• Study Start: March 1, 2016
• Primary Completion: October 9, 2017
• Study Completion: July 21, 2018
• Last Updated: October 31, 2022
• Results First Posted: October 31, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data is available in an online repository.
• Access Criteria: The data is provided in an open-access format.

Locations

GB (1)