STEM-PD Open Label Extension (OLE)
- Conditions
- Parkinson DiseaseParkinson's Disease and Parkinsonism
- Interventions
- Device: Open Label Extension Study
- Registration Number
- NCT04799418
- Lead Sponsor
- Scion NeuroStim
- Brief Summary
This study seeks to establish the safety and efficacy of extended twice daily treatments for treating symptoms associated with PD. Only participants who completed the STEM-PD RCT trial are eligible for the OLE.
- Detailed Description
Up to 220 participants will enter an open label extension (OLE) study during which all study participants will receive treatment for 12 weeks (84 days). Study participants will be followed for 16 weeks (112 days) post treatment-cessation and then the twice daily treatments will be re-introduced for the final 8 weeks (56 days).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 148
- Completion of the study activities in the STEM-PD RCT trial. l.
- Participants must be willing and able to give consent to participate in the study trial.
- Participant anticipates being unable to attend all visits and complete all study activities in both the RCT and OLE study trial.
- Women of child-bearing potential who are pregnant or plan to become pregnant during the course of the RCT or OLE study trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Treatment 1 Open Label Extension Study Study participants will self-administer \~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration.
- Primary Outcome Measures
Name Time Method Change from baseline in The International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) Total Score 8 months The MDS- NMS is 52-item rater-administered scale used to assess a wide range of non-motor symptoms in Parkinson's disease. Scores range between 0-832, with the higher score indicating greater non-motor symptom burden. (day 197 score)
- Secondary Outcome Measures
Name Time Method Change from baseline in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II 8 months 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. (day 197 score)
Change from baseline in the Clinical Global Impression - Improvement (CGI-I) 8 months The CGI-I is a clinician assessment the extent of clinically meaningful change that has occurred in the patient's illness at day 113 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.
Change from baseline in the Parkinson's Disease Quality of Life Questionnaire Summary Index (PDQ-39 SI) 8 months 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. Scores range from 0-100, with the higher scores indicating worse perception of quality of life. (day 197 score)
Change from baseline in the MDS-UPDRS Part III 8 months 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 sever motor symptoms. (day 197 score)
Trial Locations
- Locations (15)
Meridian Clinical Research
🇺🇸Raleigh, North Carolina, United States
Movement Disorder Center of Arizona
🇺🇸Scottsdale, Arizona, United States
University of Kansas Medical Center - Parkinson's Disease Center
🇺🇸Kansas City, Kansas, United States
Mercy Health Saint Mary's
🇺🇸Grand Rapids, Michigan, United States
Riverside Neurology Specialists
🇺🇸Newport News, Virginia, United States
Parkinson's Disease and Movement Disorder of Boca Raton
🇺🇸Boca Raton, Florida, United States
Quest Research
🇺🇸Farmington Hills, Michigan, United States
Veracity Neuroscience
🇺🇸Memphis, Tennessee, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Headlands Research Orlando
🇺🇸Orlando, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Houston Methodist Neurological Institute
🇺🇸Houston, Texas, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States