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The purpose of this study is to determine whether caloric vestibular stimulation improves symptoms of Parkinson's Disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caloric Vestibular Stimulation | Device | Stimulation of the vestibular nerves |
| |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Palmer | University of Kent (research ethics & governance lead) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kent | Canterbury | Kent | CT2 7NP | United Kingdom |
De-identified individual participant data for all clinical outcome measures have been made available.
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The data is available in an online repository.
The data is provided in an open-access format.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized Controlled Portion |
| |||||||||||||
| Cross-Over to Active |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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 | Posted | Median | 95% Confidence Interval | change in scale total score | Change at end of treatment (week 12) relative to the average of two baseline visits |
|
17 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arm fracture | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Wilkinson | University of Kent | +44 (0)1227 824772 | d.t.wilkinson@kent.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 25, 2018 | Mar 28, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 15, 2018 | Jul 11, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Sham Caloric Vestibular Stimulation |
| Device |
Sham stimulation of the vestibular nerves |
|
|
| 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 |
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 |
| NOT COMPLETED |
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Non-Motor Symptom Scale (NMSS) Total Score | Mean | Standard Deviation | score on a scale |
|
| MDS-UPDRS Part II Score | Mean | Standard Deviation | score on a scale |
|
| MDS-UPDRS Part III Score | Mean | Standard Deviation | score on a scale |
|
| OG001 | 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 |
|
|
|
| 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 | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 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 | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Change at end of treatment (week 12) relative to baseline average |
|
|
|
| Other Pre-specified | 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 | Not Posted | Change at one-month post-treatment follow-up (week 17) relative to baseline average | Participants |
| Other Pre-specified | 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 | Not Posted | Change at one-month post-treatment follow-up (week 17) relative to baseline average | Participants |
| Other Pre-specified | Change From Baseline in the Modified Schwab & England | clinical outcome assessment of an individual's ability to function in activities of daily living | Not Posted | Change at one-month post-treatment follow-up (week 17) relative to baseline average | Participants |
| Other Pre-specified | Change From Baseline in the 2 Minute Walk | performance measure of walking ability and functional capacity | Not Posted | Change at one-month post-treatment follow-up (week 17) relative to baseline average | Participants |
| Other Pre-specified | Change From Baseline in the 10 Meter Walk | performance measure used to assess walking speed | Not Posted | Change at one-month post-treatment follow-up (week 17) relative to baseline average | Participants |
| Other Pre-specified | Change From Baseline in the Timed Up and Go (TUG) | measures gait and the probability of falls in adults | Not Posted | Change at one-month post-treatment follow-up (week 17) relative to baseline average | Participants |
| Other Pre-specified | 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. | Not Posted | Change at one-month post-treatment follow-up (week 17) relative to baseline average | Participants |
| Other Pre-specified | 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 | Not Posted | Change at one-month post-treatment follow-up (week 17) relative to baseline average | Participants |
| Other Pre-specified | 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 | Not Posted | Change at one-month post-treatment follow-up (week 17) relative to baseline average | Participants |
| Other Pre-specified | 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 | Not Posted | Change at one-month post-treatment follow-up (week 17) relative to baseline average | Participants |
| Other Pre-specified | EEG/Event - Related Potentials Abnormalities - Physiological Measurement | Assessment of any changes to P300 during ERPs and beta wave in a resting state. | Not Posted | Change at end of treatment (week 12) relative to baseline | Participants |
| 0 |
| 23 |
| 2 |
| 23 |
| 6 |
| 23 |
| EG001 | 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 | 0 | 23 | 1 | 23 | 4 | 23 |
| EG002 | Cross-Over | Participants who received the Sham Caloric Vestibular Stimulation in the Randomized portion of the study will be receiving active caloric Vestibular Stimulation treatment for a duration of up to 4 months, 7 days a week, twice daily for 19 minutes. Caloric Vestibular Stimulation: Stimulation of the vestibular nerves | 0 | 14 | 0 | 14 | 6 | 14 |
| Knee Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Fainting Episode | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Fall | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Chest Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |