This study seeks to establish the safety and efficacy of extended twice daily time-varying caloric vestibular stimulation treatments for treating symptoms associated with Parkinson's disease. Only participants who completed the STEM-PD randomized controlled trial portion (NCT04797611) are eligible to participate in the open label extension portion.
Up to 220 participants will enter an open label extension study during which all study participants will receive active (i.e., time-varying caloric vestibular stimulation) treatment for 12 weeks (84 days). Study participants will be followed for 16 weeks (112 days) post treatment-cessation and then the twice daily active treatments will be re-introduced for the final 8 weeks (56 days).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
148
This study will investigate the safety and efficacy of extended treatments for the management of symptoms related to PD.
Movement Disorder Center of Arizona
Scottsdale, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Change From Baseline in The International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) Total Score
The primary endpoint is the change in MDS-NMS total score during the first treatment period during the open label extension (OLE) relative to the score at the end of the NCT04797611 randomized controlled trial (RCT) treatment period (day 113) for the passive-active treatment group compared to the change in MDS-NMS total score during the RCT treatment period relative to the pretreatment baseline. The MDS-NMS is 52-item rater-administered scale used to assess a wide range of non-motor symptoms in Parkinson's disease. It measures both frequency (0/never to 4/ \>51% of the time) and severity (0/not present to 4/major distress or disturbance) of 13 domains. Each question is scored by multiplying frequency x severity. All question scores for each domain are summed, and the scores for each domain are summed to provide the Total Score (range = 0-832) with the higher score indicating greater non-motor symptom burden.
Time frame: 3 months (NCT04797611 RCT: Day 29 - Day 113; This OLE: Day 113 to Day 197)
Change From Baseline in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
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. This secondary endpoint evaluates the change in the MDS-UPDRS Part II score obtained during the first treatment period of this open label extension (OLE) relative to the score obtained at the end of the NCT04797611 randomized controlled trial (RCT) period (day 113).
Time frame: 3 months (NCT04797611 RCT: Day 29 - Day 113; this OLE: Day 113 to Day 197)
Change From Baseline in the Clinical Global Impression - Improvement (CGI-I)
The CGI-I is a clinician assessment the extent of clinically meaningful change that has occurred in the patient's illness at day 197/365 relative to a baseline state (assessed at day 29). Changes in all aspects of Parkinson's disease (e.g., motor symptoms, non-motor symptoms and complications of anti-Parkinsonian medications) are considered. A "0" corresponds to no change, higher magnitude positive values correspond to greater improvements, and higher magnitude negative scores correspond to increased worsening. Scores range from -3 to +3 (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = no change, 1=minimally improved, 2=much improved, 3=very much improved).
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Parkinson's Disease and Movement Disorder of Boca Raton
Boca Raton, Florida, United States
Headlands Research Orlando
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
University of Kansas Medical Center - Parkinson's Disease Center
Kansas City, Kansas, United States
Quest Research
Farmington Hills, Michigan, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
University of New Mexico
Albuquerque, New Mexico, United States
Meridian Clinical Research
Raleigh, North Carolina, United States
...and 5 more locations
Time frame: RCT: from Baseline (Day 29) up to 3 months (Day 113); OLE: from Baseline (Day 29) up to 11 months (Day 365)
Change From Baseline in the International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination (MDS-UPDRS Part III)
The MDS-UPDRS Part III is a 33-item assessment of motor function evaluated by a trained blinded rater. Each item has five response options linked to accepted clinical terms (0/normal, 1/slight, 2/mild, 3/moderate, and 4/severe) for a total scoring range of 0-132. Higher scores indicate more severe motor symptoms. This secondary endpoint evaluates the change in MDS-UPDRS Part III score during the first treatment period of this open label extension (OLE) relative to the score at the end of the NCT04797611 randomized controlled trial (RCT) treatment period (day 113) for the passive-active treatment group compared to the change in MDS-UPDRS Part III score during the RCT treatment period relative to the pre-treatment baseline.
Time frame: 3 months (NCT04797611 RCT: Day 29 - Day 113; this OLE: Day 113 to Day 197)
Change From Baseline in the Parkinson's Disease Quality of Life Questionnaire Summary Index (PDQ-39 SI)
The PDQ-39 SI is a 39-item patient-reported quality of life measure that assesses how often people living with PD are affected across 8 dimensions of daily living covering: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (4 items), communication (3 items), and bodily discomfort (3 items). Answers for each item range from 0/never to 4/always. Each dimension is scored by summing the scores of each item, dividing that maximum possible score of all items in the dimension, and then multiplying by 100. The total score (the SI score) is the sum of all dimension scores divided by 8 and ranges from 0-100, the higher the total score the greater the health problems). This endpoint compares the change in the PDQ-39 total score taken at the end of the RCT treatment period to the total score obtained during the OLE's first treatment period.
Time frame: 3 months (NCT04797611 RCT: Day 29 - Day 113; this OLE: Day 113 to Day 197
Change From Baseline in the Combined Measure of The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Parts I, II and III
The MDS-UPDRS evaluates motor (Parts I and III) and non-motor (Part II) experiences and complications of Parkinson's disease (PD) to characterizes the extent and burden of disease. Each question has five response options linked to accepted clinical terms: (0/normal, 1/slight, 2/mild, 3/moderate, and 4/severe)/evaluations and are divided across Part I (13 questions, 52 possible points), Part II (13 questions, 52 possible points), and Part III (33 questions based on 18 items, several with right, left or other body distribution scores, 132 possible points). The Combined Score is the sum of the points for all three Parts and ranges from 0 to 236. The higher the score, the more progressed (i.e., worse) is the disease state. The more negative the change score the greater the symptomatic improvement.
Time frame: 3 months (NCT04797611 RCT: Day 29 - Day 113; this OLE: Day 113 to Day 197