Back to resultsSTEM-PD Open Label Extension (OLE)
Primary Purpose
Parkinson Disease, Parkinson's Disease and Parkinsonism
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Open Label Extension Study
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Open Label Extension Study, Medical Devices, Non-Motor Symptoms (NMS), Non-Invasive Brain Stimulation, Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Movement Disorder Center of Arizona
- Cedars-Sinai Medical Center
- Parkinson's Disease and Movement Disorder of Boca Raton
- Headlands Research Orlando
- University of South Florida
- University of Kansas Medical Center - Parkinson's Disease Center
- Quest Research
- Mercy Health Saint Mary's
- University of New Mexico
- Meridian Clinical Research
- Cleveland Clinic
- Medical University of South Carolina
- Veracity Neuroscience
- Houston Methodist Neurological Institute
- Riverside Neurology Specialists
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental Treatment 1
Arm Description
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.
Outcomes
Primary Outcome Measures
Change from baseline in The International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) Total Score
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
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. (day 197 score)
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 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 MDS-UPDRS Part III
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)
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. Scores range from 0-100, with the higher scores indicating worse perception of quality of life. (day 197 score)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04799418
Brief Title
STEM-PD Open Label Extension (OLE)
Official Title
Non-Invasive Brainstem Modulation for the Treatment of Non-Motor Symptoms in Parkinson's Disease: An Open Label Extension (OLE) Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scion NeuroStim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
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.
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Parkinson's Disease and Parkinsonism
Keywords
Open Label Extension Study, Medical Devices, Non-Motor Symptoms (NMS), Non-Invasive Brain Stimulation, Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Treatment 1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Open Label Extension Study
Intervention Description
This study will investigate the safety and efficacy of extended treatments for the management of symptoms related to PD.
Primary Outcome Measure Information:
Title
Change from baseline in The International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) Total Score
Description
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)
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Change from baseline in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
Description
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)
Time Frame
8 months
Title
Change from baseline in the Clinical Global Impression - Improvement (CGI-I)
Description
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.
Time Frame
8 months
Title
Change from baseline in the MDS-UPDRS Part III
Description
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)
Time Frame
8 months
Title
Change from baseline in the Parkinson's Disease Quality of Life Questionnaire Summary Index (PDQ-39 SI)
Description
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)
Time Frame
8 months
Other Pre-specified Outcome Measures:
Title
Change from baseline in the Mini-Balance Evaluation Systems Test
Description
a measure of dynamic balance, functional mobility, and gait. This measure will be evaluated as a safety outcome to assess whether device therapy negatively impacts balance or gait for participants with Parkinson's disease (day 197 score)
Time Frame
8 months
Title
Change from baseline in the Montreal Cognitive Assessment
Description
a screening instrument used to facilitate the assessment of cognitive impairment.
Time Frame
8 months
Title
Change from baseline in the Oral Symbol Digit Modality Test
Description
a brief and commonly used tests to evaluate processing speed
Time Frame
8 months
Title
Change from baseline in the Parkinson's Disease Sleep Scale
Description
an assessment to quantify nocturnal sleep issues in Parkinson's disease
Time Frame
8 months
Title
Change from baseline in Epworth Sleepiness Scale
Description
a brief measure that is commonly used to assess daytime sleepiness
Time Frame
8 months
Title
Change from baseline in the Parkinson Anxiety Scale
Description
a brief questionnaire to detect anxiety severity in Parkinson's disease
Time Frame
8 months
Title
Change from baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue Scale
Description
a measure of an individual's level of fatigue during their usual daily activities over the past week
Time Frame
8 months
Title
Change from baseline in the Geriatric Depression Scale-15
Description
a short questionnaire for assessing depression in older adults
Time Frame
8 months
Title
Change from baseline in the MDS-NMS Non-Motor Fluctuations
Description
a rater completed assessment evaluating fluctuations of non-motor symptoms in Parkinson's disease
Time Frame
8 months
Title
Change from baseline in the Unified Parkinson's Disease Rating Scale Part IV
Description
an assessment of complications of anti-Parkinsonian therapies
Time Frame
8 months
Title
Change from baseline in a Non-Motor Symptom focused Clinical Global Impression-Improvement
Description
clinician assessment the extent of clinically meaningful change that has occurred as it relates to the patient's non-motor symptoms
Time Frame
8 months
Title
Change from baseline in the Zarit Burden Interview
Description
measure of caregiving burden completed by caregivers
Time Frame
8 months
Title
Change from baseline in the Patient Reported Outcome - Parkinson's Disease
Description
a self-rating tool to assess symptom severity in Parkinson's disease
Time Frame
8 months
Title
Change from baseline in The Modified Schwab and England Activities of Daily Living Scale
Description
a clinical outcome assessment of an individual's ability to function independently in activities of daily living
Time Frame
8 months
Title
Change from baseline in EncephaLogTM 3 meter Timed Up and Go Test
Description
smart phone application assessment that provides indication of risk of falls in adults
Time Frame
8 months
Title
Change from baseline in EncephaLogTM finger tapping test
Description
smart phone application providing a quantitative measure of bradykinesia
Time Frame
8 months
Title
Change from baseline in EncephaLogTM 10m Timed Up and Go (10m TUG)
Description
smart phone application that measures gait and that provides indication of risk of falls in adults
Time Frame
8 months
Title
Change from baseline in Unified Parkinson's disease Rating Scale Part I (UPDRS I)
Description
a measure of mentation, behavior, and mood in Parkinson's disease
Time Frame
8 months
Title
Change from baseline in Hoehn & Yahr (H&Y)
Description
staging tool describing the level of disability in Parkinson's disease
Time Frame
8 months
Title
Change from baseline in Patient Global Impression of Improvement
Description
a patient determined scale to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Movement Disorder Center of Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Parkinson's Disease and Movement Disorder of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Headlands Research Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
University of Kansas Medical Center - Parkinson's Disease Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Quest Research
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Mercy Health Saint Mary's
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Meridian Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Veracity Neuroscience
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38157
Country
United States
Facility Name
Houston Methodist Neurological Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Riverside Neurology Specialists
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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STEM-PD Open Label Extension (OLE)
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