N/A
N=46
Vestibular Stimulation in Parkinson's Disease
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02703844 ↗Enrolled (actual)
46
Serious AEs
5.0%
Results posted
Oct 2022
Primary outcome: Primary: Change From Baseline in the Nonmotor Symptom Severity Scale (NMSS) — -33.5; -2.0 change in scale total score — p=0.0089
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Caloric Vestibular Stimulation (Device); Sham Caloric Vestibular Stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Kent
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Nonmotor Symptom Severity Scale (NMSS) |
-33.5; -2.0 | 0.0089 sig |
| SECONDARY Change From Baseline in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II: Motor Aspects of Experiences of Daily Living |
-3.2; -0.4 | — |
| SECONDARY Change From Baseline in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III: Motor Examination |
-8.8; -2.8 | — |
Summary
The purpose of this study is to determine whether caloric vestibular stimulation improves symptoms of Parkinson's Disease.
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
Data sourced from ClinicalTrials.gov (NCT02703844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.