Vestibular Stimulation in Parkinson's Disease

• ClinicalTrials.gov Identifier: NCT02703844
• Recruitment Status: Completed
• First Posted: March 9, 2016
• Results First Posted: October 31, 2022
• Last Update Posted: October 31, 2022
• Sponsor: University of Kent
• Information provided by (Responsible Party): University of Kent

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Parkinson's Disease	Device: Caloric Vestibular Stimulation; Device: Sham Caloric Vestibular Stimulation	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Caloric Vestibular Stimulation in Parkinson's Disease
• Study Start Date: March 2016
• Actual Primary Completion Date: October 9, 2017
• Actual Study Completion Date: July 21, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Device: Caloric Vestibular Stimulation; Stimulation of the vestibular nerves
Sham Comparator: 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.	Device: Sham Caloric Vestibular Stimulation; Sham stimulation of the vestibular nerves; Other Name: Placebo

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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 ]
   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
2. 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 ]
   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 Outcome Measures:

1. Change From Baseline in the Montreal Cognitive Assessment [ Time Frame: 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
2. Change From Baseline in the Epworth Sleepiness Scale [ Time Frame: 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
3. Change From Baseline in the Modified Schwab & England [ Time Frame: 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
4. Change From Baseline in the 2 Minute Walk [ Time Frame: Change at one-month post-treatment follow-up (week 17) relative to baseline average ]
   performance measure of walking ability and functional capacity
5. Change From Baseline in the 10 Meter Walk [ Time Frame: Change at one-month post-treatment follow-up (week 17) relative to baseline average ]
   performance measure used to assess walking speed
6. Change From Baseline in the Timed Up and Go (TUG) [ Time Frame: Change at one-month post-treatment follow-up (week 17) relative to baseline average ]
   measures gait and the probability of falls in adults
7. Change From Baseline in the Fatigue Severity Scale [ Time Frame: 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.
8. Change From Baseline in the EuroQol 5D [ Time Frame: 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
9. Change From Baseline in the SF-12 Health Survey [ Time Frame: 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
10. Change From Baseline in the Hospital Anxiety and Depression Scale [ Time Frame: 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
11. EEG/Event - Related Potentials Abnormalities - Physiological Measurement [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 95 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United Kingdom

University of Kent

Canterbury, Kent, United Kingdom, CT2 7NP

Sponsors and Collaborators

University of Kent

Investigators

• Study Director: Nicole Palmer; University of Kent (research ethics & governance lead)

  Study Documents (Full-Text)

Documents provided by University of Kent:

Study Protocol  [PDF] July 25, 2018

Statistical Analysis Plan  [PDF] August 15, 2018

More Information

• Responsible Party: University of Kent
• ClinicalTrials.gov Identifier: NCT02703844
• Other Study ID Numbers: KENT/DW/PD/2016
• First Posted: March 9, 2016
• Results First Posted: October 31, 2022
• Last Update Posted: October 31, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified individual participant data for all clinical outcome measures have been made available.
• Time Frame: The data is available in an online repository.
• Access Criteria: The data is provided in an open-access format.
• URL: https://data.mendeley.com/datasets/m7ths6gdv9/1

• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases