Vestibular Stimulation in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Caloric Vestibular Stimulation in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703844
• Other study ID #: KENT/DW/PD/2016
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: July 21, 2018

Study information

• Verified date: October 2022
• Source: University of Kent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 21, 2018
• Est. primary completion date: October 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Caloric Vestibular Stimulation
Stimulation of the vestibular nerves
• Sham Caloric Vestibular Stimulation
Sham stimulation of the vestibular nerves

Locations

Country	Name	City	State
United Kingdom	University of Kent	Canterbury	Kent

Sponsors (1)

Lead Sponsor	Collaborator
University of Kent

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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