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STEM-PD Open Label Extension (OLE)

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: NCT04799418
Recruitment Status : Enrolling by invitation
First Posted : March 16, 2021
Last Update Posted : October 25, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Parkinson's Disease and Parkinsonism Device: Open Label Extension Study Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-Invasive Brainstem Modulation for the Treatment of Non-Motor Symptoms in Parkinson's Disease: An Open Label Extension (OLE) Study
Actual Study Start Date : September 15, 2022
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024


Arm Intervention/treatment
Experimental: Experimental Treatment 1
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.
Device: Open Label Extension Study
This study will investigate the safety and efficacy of extended treatments for the management of symptoms related to PD.




Primary Outcome Measures :
  1. Change from baseline in The International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) Total Score [ Time Frame: 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 :
  1. Change from baseline in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II [ Time Frame: 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)

  2. Change from baseline in the Clinical Global Impression - Improvement (CGI-I) [ Time Frame: 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.

  3. Change from baseline in the MDS-UPDRS Part III [ Time Frame: 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)

  4. Change from baseline in the Parkinson's Disease Quality of Life Questionnaire Summary Index (PDQ-39 SI) [ Time Frame: 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)


Other Outcome Measures:
  1. Change from baseline in the Mini-Balance Evaluation Systems Test [ Time Frame: 8 months ]
    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)

  2. Change from baseline in the Montreal Cognitive Assessment [ Time Frame: 8 months ]
    a screening instrument used to facilitate the assessment of cognitive impairment.

  3. Change from baseline in the Oral Symbol Digit Modality Test [ Time Frame: 8 months ]
    a brief and commonly used tests to evaluate processing speed

  4. Change from baseline in the Parkinson's Disease Sleep Scale [ Time Frame: 8 months ]
    an assessment to quantify nocturnal sleep issues in Parkinson's disease

  5. Change from baseline in Epworth Sleepiness Scale [ Time Frame: 8 months ]
    a brief measure that is commonly used to assess daytime sleepiness

  6. Change from baseline in the Parkinson Anxiety Scale [ Time Frame: 8 months ]
    a brief questionnaire to detect anxiety severity in Parkinson's disease

  7. Change from baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue Scale [ Time Frame: 8 months ]
    a measure of an individual's level of fatigue during their usual daily activities over the past week

  8. Change from baseline in the Geriatric Depression Scale-15 [ Time Frame: 8 months ]
    a short questionnaire for assessing depression in older adults

  9. Change from baseline in the MDS-NMS Non-Motor Fluctuations [ Time Frame: 8 months ]
    a rater completed assessment evaluating fluctuations of non-motor symptoms in Parkinson's disease

  10. Change from baseline in the Unified Parkinson's Disease Rating Scale Part IV [ Time Frame: 8 months ]
    an assessment of complications of anti-Parkinsonian therapies

  11. Change from baseline in a Non-Motor Symptom focused Clinical Global Impression-Improvement [ Time Frame: 8 months ]
    clinician assessment the extent of clinically meaningful change that has occurred as it relates to the patient's non-motor symptoms

  12. Change from baseline in the Zarit Burden Interview [ Time Frame: 8 months ]
    measure of caregiving burden completed by caregivers

  13. Change from baseline in the Patient Reported Outcome - Parkinson's Disease [ Time Frame: 8 months ]
    a self-rating tool to assess symptom severity in Parkinson's disease

  14. Change from baseline in The Modified Schwab and England Activities of Daily Living Scale [ Time Frame: 8 months ]
    a clinical outcome assessment of an individual's ability to function independently in activities of daily living

  15. Change from baseline in EncephaLogTM 3 meter Timed Up and Go Test [ Time Frame: 8 months ]
    smart phone application assessment that provides indication of risk of falls in adults

  16. Change from baseline in EncephaLogTM finger tapping test [ Time Frame: 8 months ]
    smart phone application providing a quantitative measure of bradykinesia

  17. Change from baseline in EncephaLogTM 10m Timed Up and Go (10m TUG) [ Time Frame: 8 months ]
    smart phone application that measures gait and that provides indication of risk of falls in adults

  18. Change from baseline in Unified Parkinson's disease Rating Scale Part I (UPDRS I) [ Time Frame: 8 months ]
    a measure of mentation, behavior, and mood in Parkinson's disease

  19. Change from baseline in Hoehn & Yahr (H&Y) [ Time Frame: 8 months ]
    staging tool describing the level of disability in Parkinson's disease

  20. Change from baseline in Patient Global Impression of Improvement [ Time Frame: 8 months ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT04799418


Locations
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United States, Arizona
Movement Disorder Center of Arizona
Scottsdale, Arizona, United States, 85258
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
Parkinson's Disease and Movement Disorder of Boca Raton
Boca Raton, Florida, United States, 33486
Headlands Research Orlando
Orlando, Florida, United States, 32819
University of South Florida
Tampa, Florida, United States, 33613
United States, Kansas
University of Kansas Medical Center - Parkinson's Disease Center
Kansas City, Kansas, United States, 66160
United States, Michigan
Quest Research
Farmington Hills, Michigan, United States, 48334
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
Meridian Clinical Research
Raleigh, North Carolina, United States, 27607
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Veracity Neuroscience
Memphis, Tennessee, United States, 38157
United States, Texas
Houston Methodist Neurological Institute
Houston, Texas, United States, 77030
United States, Virginia
Riverside Neurology Specialists
Newport News, Virginia, United States, 23601
Sponsors and Collaborators
Scion NeuroStim
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Responsible Party: Scion NeuroStim
ClinicalTrials.gov Identifier: NCT04799418    
Other Study ID Numbers: SNS-PD-003
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: October 25, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Scion NeuroStim:
Open Label Extension Study
Medical Devices
Non-Motor Symptoms (NMS)
Non-Invasive Brain Stimulation
Parkinson Disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases