Vestibular Stimulation in Parkinson's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02703844|
Recruitment Status : Active, not recruiting
First Posted : March 9, 2016
Last Update Posted : May 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease and Parkinsonism||Device: Caloric Vestibular Stimulation Device: Sham Caloric Vestibular Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Caloric Vestibular Stimulation in Parkinson's Disease|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Active
Participants will be receiving an active Caloric Vestibular Stimulation treatment for a duration of 12 weeks, 7 days a week, twice daily for 20 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 12 weeks in the same manner as the active arm: 7 days a week, twice daily for 20 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
- Unified Parkinson's Disease Rating Scale (UPDRS). questionnaire [ Time Frame: 16 weeks ]We expect changes mainly in the motor subscale.
- 2 Minute Walk behavioural measurement [ Time Frame: 16 weeks ]Distance walked by the patient in 2 minutes is measured.
- 10 Meter Walk behavioural measurement [ Time Frame: 16 weeks ]An average time of a normal-speed and fast-speed of gait on a distance of 10 meters taken three times is measured.
- Timed Up and Go behavioural measurement [ Time Frame: 16 weeks ]time taken to get up from a chair, walk 3 meters, go back and sit down is measured.
- Montreal Cognitive Assessment (MoCA) Questionnaire [ Time Frame: 16 weeks ]cognitive ability test
- EQ-5D-3L Questionnaire [ Time Frame: 16 weeks ]Activity of daily living scale
- Schwab and England Scale Questionnaire [ Time Frame: 16 weeks ]Health Questionnaire
- PD-39 Questionnaire [ Time Frame: 16 weeks ]Health-related Parkinson's Disease questionnaire
- Hospital Anxiety and Depression Scale Questionnaire [ Time Frame: 16 weeks ]depression and anxiety questionnaire
- Epworth Sleepiness Scale Questionnaire [ Time Frame: 16 weeks ]
- Fatigue Severity Scale Questionnaire [ Time Frame: 16 weeks ]
- EEG/Event - Related Potentials abnormalities - Physiological measurement [ Time Frame: 16 weeks ]Assessment of any changes to P300 during ERPs and beta wave in a resting state.
- SPECT DaTSCAN - Physiological measurement [ Time Frame: 16 weeks ]Assessment of any changes in the concentration of dopamine within the central nervous system
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703844
|University of Kent|
|Canterbury, Kent, United Kingdom, CT2 7NP|