Parkinson's DiseaseNCT02703844
Vestibular Stimulation in Parkinson's Disease
A study testing Caloric Vestibular Stimulation in people with Parkinson's Disease, run by University of Kent at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether caloric vestibular stimulation improves symptoms of Parkinson's Disease. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Caloric Vestibular Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to 21 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caloric Vestibular Stimulation in Parkinson's Disease
The purpose of this study is to determine whether caloric vestibular stimulation improves symptoms of Parkinson's Disease.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Caloric Vestibular Stimulation, Sham Caloric Vestibular Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric Vestibular StimulationDevice
Stimulation of the vestibular nerves
Sham Caloric Vestibular StimulationDevice
Also called Placebo
Sham stimulation of the vestibular nerves
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Caloric Vestibular Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
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
Measured: Change at end of treatment (week 12) relative to baseline average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion9 Oct 2017
- Study completion21 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Palmer, Study director, University of Kent (research ethics & governance lead)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703844
- Sponsor's protocol ID
- KENT/DW/PD/2016
- Status last verified
- Oct 2022
- First submitted
- 26 Feb 2016
- Last updated
- 31 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data for all clinical outcome measures have been made available.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caloric Vestibular Stimulation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02703844
- Acronym / sponsor ID
- KENT/DW/PD/2016
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of KentUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 9 Oct 2017 (actual)
- Study completion
- 21 Jul 2018 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Posted 31 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: Caloric Vestibular StimulationParticipants 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 | Device: Sham Caloric Vestibular StimulationParticipants 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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caloric Vestibular StimulationStimulation of the vestibular nerves | Device | Active |
| Sham Caloric Vestibular StimulationAlso: PlaceboSham stimulation of the vestibular nerves | Device | Placebo |
Primary outcome
Change From Baseline in the Nonmotor Symptom Severity Scale (NMSS)
Time frame: 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
2 secondary outcomes
Change From Baseline in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II: Motor Aspects of Experiences of Daily Living
Time frame: 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
Time frame: Change at end of treatment (week 12) relative to baseline average
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all clinical outcome measures have been made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Palmer study director
University of Kent (research ethics & governance lead)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric Vestibular Stimulation in people with Parkinson's Disease, run by University of Kent at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Nonmotor Symptom Severity Scale (NMSS) (time frame: Change at end of treatment (week 12) relative to the average of two baseline visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.