Clinical trial NCT04799418: 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
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Parkinson's Disease and Parkinsonism
Keywords: Open Label Extension Study
Medical Devices
Non-Motor Symptoms (NMS)
Non-Invasive Brain Stimulation
Parkinson Disease
Lead sponsor: Scion NeuroStim
Sponsor class: INDUSTRY
First posted: 2021-03-16
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change from baseline in The International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) Total Score
timeFrame: 8 months
Secondary outcomes:
measure: Change from baseline in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
timeFrame: 8 months
measure: Change from baseline in the Clinical Global Impression - Improvement (CGI-I)
timeFrame: 8 months
measure: Change from baseline in the MDS-UPDRS Part III
timeFrame: 8 months
measure: Change from baseline in the Parkinson's Disease Quality of Life Questionnaire Summary Index (PDQ-39 SI)
timeFrame: 8 months
Other outcomes:
measure: Change from baseline in the Mini-Balance Evaluation Systems Test
timeFrame: 8 months
measure: Change from baseline in the Montreal Cognitive Assessment
timeFrame: 8 months
measure: Change from baseline in the Oral Symbol Digit Modality Test
timeFrame: 8 months
measure: Change from baseline in the Parkinson's Disease Sleep Scale
timeFrame: 8 months
measure: Change from baseline in Epworth Sleepiness Scale
timeFrame: 8 months
measure: Change from baseline in the Parkinson Anxiety Scale
timeFrame: 8 months
measure: Change from baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue Scale
timeFrame: 8 months
measure: Change from baseline in the Geriatric Depression Scale-15
timeFrame: 8 months
measure: Change from baseline in the MDS-NMS Non-Motor Fluctuations
timeFrame: 8 months
measure: Change from baseline in the Unified Parkinson's Disease Rating Scale Part IV
timeFrame: 8 months
measure: Change from baseline in a Non-Motor Symptom focused Clinical Global Impression-Improvement
timeFrame: 8 months
measure: Change from baseline in the Zarit Burden Interview
timeFrame: 8 months
measure: Change from baseline in the Patient Reported Outcome - Parkinson's Disease
timeFrame: 8 months
measure: Change from baseline in The Modified Schwab and England Activities of Daily Living Scale
timeFrame: 8 months
measure: Change from baseline in EncephaLogTM 3 meter Timed Up and Go Test
timeFrame: 8 months
measure: Change from baseline in EncephaLogTM finger tapping test
timeFrame: 8 months
measure: Change from baseline in EncephaLogTM 10m Timed Up and Go (10m TUG)
timeFrame: 8 months
measure: Change from baseline in Unified Parkinson's disease Rating Scale Part I (UPDRS I)
timeFrame: 8 months
measure: Change from baseline in Hoehn & Yahr (H&Y)
timeFrame: 8 months
measure: Change from baseline in Patient Global Impression of Improvement
timeFrame: 8 months
Locations:
city: Scottsdale
country: United States
facility: Movement Disorder Center of Arizona
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorder of Boca Raton
state: Florida
city: Orlando
country: United States
facility: Headlands Research Orlando
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center - Parkinson's Disease Center
state: Kansas
city: Farmington Hills
country: United States
facility: Quest Research
state: Michigan
city: Grand Rapids
country: United States
facility: Mercy Health Saint Mary's
state: Michigan
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Raleigh
country: United States
facility: Meridian Clinical Research
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Veracity Neuroscience
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Neurological Institute
state: Texas
city: Newport News
country: United States
facility: Riverside Neurology Specialists
state: Virginia
Study officials:
References: