Vestibular Stimulation in Parkinson's Disease

Caloric Vestibular Stimulation in Parkinson's Disease

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02703844

Enrollment

Registered

2016-03-09

Start date

2016-03-31

Completion date

2018-07-21

Last updated

2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

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.

Interventions

DEVICECaloric Vestibular Stimulation

Stimulation of the vestibular nerves

DEVICESham Caloric Vestibular Stimulation

Sham stimulation of the vestibular nerves

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in the Nonmotor Symptom Severity Scale (NMSS)	Change at end of treatment (week 12) relative to the average of two baseline visits	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

Secondary

Measure	Time frame	Description
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	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 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	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

Other

Measure	Time frame	Description
Change From Baseline in the 2 Minute Walk	Change at one-month post-treatment follow-up (week 17) relative to baseline average	performance measure of walking ability and functional capacity
Change From Baseline in the 10 Meter Walk	Change at one-month post-treatment follow-up (week 17) relative to baseline average	performance measure used to assess walking speed
Change From Baseline in the Timed Up and Go (TUG)	Change at one-month post-treatment follow-up (week 17) relative to baseline average	measures gait and the probability of falls in adults
Change From Baseline in the Fatigue Severity Scale	Change at one-month post-treatment follow-up (week 17) relative to baseline average	questionnaire for evaluating the impact of fatigue. scores range from 9-63 with a higher score for greater fatigue.
Change From Baseline in the Modified Schwab & England	Change at one-month post-treatment follow-up (week 17) relative to baseline average	clinical outcome assessment of an individual's ability to function in activities of daily living
Change From Baseline in the SF-12 Health Survey	Change at one-month post-treatment follow-up (week 17) relative to baseline average	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 From Baseline in the Hospital Anxiety and Depression Scale	Change at one-month post-treatment follow-up (week 17) relative to baseline average	self-rating scale developed to assess psychological distress. scores range between 0-21 with higher scores equaling more severe impairment
EEG/Event - Related Potentials Abnormalities - Physiological Measurement	Change at end of treatment (week 12) relative to baseline	Assessment of any changes to P300 during ERPs and beta wave in a resting state.
Change From Baseline in the EuroQol 5D	Change at one-month post-treatment follow-up (week 17) relative to baseline average	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 From Baseline in the Montreal Cognitive Assessment	Change at one-month post-treatment follow-up (week 17) relative to baseline average	rapid screening instrument for mild cognitive dysfunction, with a score range from zero to 30, with higher being closer to normal
Change From Baseline in the Epworth Sleepiness Scale	Change at one-month post-treatment follow-up (week 17) relative to baseline average	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

Countries

United Kingdom

Participant flow

Participants by arm

Arm	Count
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. Caloric Vestibular Stimulation: Stimulation of the vestibular nerves	23
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. Sham Caloric Vestibular Stimulation: Sham stimulation of the vestibular nerves	23
Total	46

Baseline characteristics

Characteristic	Active	Placebo	Total
Age, Continuous	69.7 years STANDARD_DEVIATION 11.3	72.2 years STANDARD_DEVIATION 6.6	70.9 years STANDARD_DEVIATION 9.2
MDS-UPDRS Part III Score	49.3 score on a scale STANDARD_DEVIATION 17.6	45.4 score on a scale STANDARD_DEVIATION 16.3	47.4 score on a scale STANDARD_DEVIATION 16.9
MDS-UPDRS Part II Score	22.5 score on a scale STANDARD_DEVIATION 9.1	21.4 score on a scale STANDARD_DEVIATION 5.3	21.9 score on a scale STANDARD_DEVIATION 7.4
Non-Motor Symptom Scale (NMSS) Total Score	126.2 score on a scale STANDARD_DEVIATION 29.8	117.7 score on a scale STANDARD_DEVIATION 32.6	122 score on a scale STANDARD_DEVIATION 31.2
Race and Ethnicity Not Collected	—	—	0 Participants
Sex: Female, Male Female	11 Participants	5 Participants	16 Participants
Sex: Female, Male Male	12 Participants	18 Participants	30 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 23	0 / 23	0 / 14
other Total, other adverse events	6 / 23	4 / 23	6 / 14
serious Total, serious adverse events	2 / 23	1 / 23	0 / 14

Outcome results

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

Time frame: Change at end of treatment (week 12) relative to the average of two baseline visits

Population: data reported for this outcome includes anyone who received at least one treatment with the study device and had a baseline NMSS performed. Change scores were not normally distributed and therefore nonparametric tests were used and medians are reported

Arm	Measure	Value (MEDIAN)
Active	Change From Baseline in the Nonmotor Symptom Severity Scale (NMSS)	-33.5 change in scale total score
Placebo	Change From Baseline in the Nonmotor Symptom Severity Scale (NMSS)	-2.0 change in scale total score

p-value: 0.0089ANCOVA

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

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

Population: data reported for this outcome includes anyone who received at least one treatment with the study device and had a baseline MDS-UPDRS Part III performed.

Arm	Measure	Value (MEAN)
Active	Change From Baseline in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III: Motor Examination	-8.8 score on a scale
Placebo	Change From Baseline in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III: Motor Examination	-2.8 score on a scale

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

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

Population: data reported for this outcome includes anyone who received at least one treatment with the study device and had a baseline MDS-UPDRS Part II performed.

Arm	Measure	Value (MEAN)
Active	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 score on a scale
Placebo	Change From Baseline in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II: Motor Aspects of Experiences of Daily Living	-0.4 score on a scale

Other Pre-specified