STEM-PD Open Label Extension (OLE)

Non-Invasive Brainstem Modulation for the Treatment of Non-Motor Symptoms in Parkinson's Disease: An Open Label Extension (OLE) Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Parkinson Disease; Parkinson's Disease and Parkinsonism
• Intervention / Treatment: Device: Open Label Extension Study

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).

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Movement Disorder Center of Arizona
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorder of Boca Raton
    • Orlando, Florida, United States, 32819
      • Headlands Research Orlando
    • Tampa, Florida, United States, 33613
      • University of South Florida
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center - Parkinson's Disease Center
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research
    • Grand Rapids, Michigan, United States, 49503
      • Mercy Health Saint Mary's
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Meridian Clinical Research
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Memphis, Tennessee, United States, 38157
      • Veracity Neuroscience
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Neurological Institute
  • Virginia
    • Newport News, Virginia, United States, 23601
      • Riverside Neurology Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	8 months
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.	8 months
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)	8 months
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)	8 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the Mini-Balance Evaluation Systems Test	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)	8 months
Change from baseline in the Montreal Cognitive Assessment	a screening instrument used to facilitate the assessment of cognitive impairment.	8 months
Change from baseline in the Oral Symbol Digit Modality Test	a brief and commonly used tests to evaluate processing speed	8 months
Change from baseline in the Parkinson's Disease Sleep Scale	an assessment to quantify nocturnal sleep issues in Parkinson's disease	8 months
Change from baseline in Epworth Sleepiness Scale	a brief measure that is commonly used to assess daytime sleepiness	8 months
Change from baseline in the Parkinson Anxiety Scale	a brief questionnaire to detect anxiety severity in Parkinson's disease	8 months
Change from baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue Scale	a measure of an individual's level of fatigue during their usual daily activities over the past week	8 months
Change from baseline in the Geriatric Depression Scale-15	a short questionnaire for assessing depression in older adults	8 months
Change from baseline in the MDS-NMS Non-Motor Fluctuations	a rater completed assessment evaluating fluctuations of non-motor symptoms in Parkinson's disease	8 months
Change from baseline in the Unified Parkinson's Disease Rating Scale Part IV	an assessment of complications of anti-Parkinsonian therapies	8 months
Change from baseline in a Non-Motor Symptom focused Clinical Global Impression-Improvement	clinician assessment the extent of clinically meaningful change that has occurred as it relates to the patient's non-motor symptoms	8 months
Change from baseline in the Zarit Burden Interview	measure of caregiving burden completed by caregivers	8 months
Change from baseline in the Patient Reported Outcome - Parkinson's Disease	a self-rating tool to assess symptom severity in Parkinson's disease	8 months
Change from baseline in The Modified Schwab and England Activities of Daily Living Scale	a clinical outcome assessment of an individual's ability to function independently in activities of daily living	8 months
Change from baseline in EncephaLogTM 3 meter Timed Up and Go Test	smart phone application assessment that provides indication of risk of falls in adults	8 months
Change from baseline in EncephaLogTM finger tapping test	smart phone application providing a quantitative measure of bradykinesia	8 months
Change from baseline in EncephaLogTM 10m Timed Up and Go (10m TUG)	smart phone application that measures gait and that provides indication of risk of falls in adults	8 months
Change from baseline in Unified Parkinson's disease Rating Scale Part I (UPDRS I)	a measure of mentation, behavior, and mood in Parkinson's disease	8 months
Change from baseline in Hoehn & Yahr (H&Y)	staging tool describing the level of disability in Parkinson's disease	8 months
Change from baseline in Patient Global Impression of Improvement	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	8 months

Collaborators and Investigators

• Sponsor: Scion NeuroStim

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Parkinson Disease; Non-Invasive Brain Stimulation; Medical Devices; Non-Motor Symptoms (NMS); Open Label Extension Study
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Parkinsonian Disorders
• Other Study ID Numbers: SNS-PD-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No