STEM-Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Non-Invasive Brainstem Modulation for the Treatment of Non-Motor Symptoms in Parkinson's Disease: A Randomized Controlled Trial (RCT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04797611
• Other study ID #: SNS-PD-002
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2022
• Est. completion date: October 2024

Study information

• Verified date: January 2024
• Source: Scion NeuroStim
• Contact: Kara Richardson
• Phone: (984) 884-1020
• Email: krichardson[@]scionneurostim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a double-blinded, controlled, randomized clinical trial (RCT) to establish the safety and efficacy of a non-invasive neuromodulation device for treating symptoms associated with Parkinson's disease.

Description:

Up to 218 participants will enter the double-blinded, controlled, randomized clinical trial (RCT) and will self-administer treatments twice daily in the home setting over a period of 12 weeks following a 4 week baseline period. The RCT will have 6 study visits: 3 visits at the study center and 3 visits completed in the participant's home by video call.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 218
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Adult participants (aged 18 - 85 years inclusive)
• Diagnosed with Parkinson's disease according to the UK Brain Bank Criteria
• Demonstrates a positive response to oral anti-Parkinsonian medications (i.e. dopamine replacement therapies) and treated with these medications for minimum of one year prior to the screening visit
• Report limitation to activities of daily living (e.g., writing, walking, bathing, dressing, eating, toileting, etc.)
• Able and willing to consent to participate in the study.
• Willing and able to comply with study requirements.
• Anticipate being able to remain on a stable regimen of medications used for the management of PD motor and non-motor symptoms and not to introduce new medications used to treat symptoms associated with PD during the trial.
• Have at minimum a moderate burden of non-motor symptoms associated with Parkinson's disease
• Have a study partner (defined as someone who sees the participant for more than one hour a day, 3 times per week) that is willing to consent and participate in the trial.
• Have capabilities to use and access smartphones and or tablets for the collection of some study data.
• Must be willing to answer questions related to sexual interest, arousal, and performance in an interview with study staff.

Exclusion Criteria:

• Participant anticipates being unable to attend all visits and complete all study activities.
• Women of child-bearing potential who are pregnant or plan to become pregnant during the course of the study trial. Women of child-bearing potential , who are not

abstinent or exclusively in same sex relationships must:

1. Test negative for pregnancy as indicated by a negative urine pregnancy test

2. Agree to use an approved contraception method for the entirety of the trial

• Have a history or prior diagnosis of dementia or evidence of dementia at study screen.
• Have experienced a myocardial infarction, angina, or stroke within the past 12 months, or a transient ischemic attack within the past 6 months.
• Are receiving deep brain stimulation therapy.
• Are treated with a pump for continuous delivery of dopamine replacement medication.
• Use apomorphine rescue.
• Have received MRI guided high intensity focused ultrasound within the past 12 months.
• Experience frequent falls.
• Work night shifts
• Use a hearing aid that is implanted or that cannot be easily removed and replaced.
• Have a cochlear implant.
• Have chronic (>3 months) tinnitus.
• Have previously been diagnosed with traumatic brain injury with ongoing sequalae.
• Have been diagnosed with a co-morbid neurological disorder that may present with symptoms overlapping with PD (e.g., stroke, brain tumor, epilepsy, Alzheimer's disease, multiple sclerosis, amyotrophic lateral sclerosis, atypical Parkinsonism or aneurysm)
• Have unresolved complications from a previous surgical procedure at the baseline visits, such as swelling or persistent pain, that requires medical intervention.
• Have active ear infections, or other significant ear problems.
• Have a recent history of frequent ear infections (= 1 per year over the past two years)
• Are currently enrolled or have participated in another interventional clinical trial within the last 30 days.
• Have had eye surgery within the previous three months or ear surgery within the previous six months.
• Have planned surgery scheduled to occur during the study that requires sedation and/or would typically be followed with a prescription for pain management.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease and Parkinsonism
• Parkinsonian Disorders

Intervention

Device:
• Non-invasive brainstem stimulation
Study participants will self-administer ~19-minute treatments twice daily in the home setting over 12 weeks using a non-invasive brainstem modulation device. The device has been deemed to be a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration.

Locations

Country	Name	City	State
United Kingdom	King's College Hospital NHS Foundation Trust	London
United States	University of New Mexico	Albuquerque	New Mexico
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	CenExel Rocky Mountain Clinical Research	Englewood	Colorado
United States	Quest Research	Farmington Hills	Michigan
United States	Texas Movement Disorder Specialist	Georgetown	Texas
United States	Mercy Health Saint Mary's	Grand Rapids	Michigan
United States	Houston Methodist Neurological Institute	Houston	Texas
United States	University of Kansas Medical Center - Parkinson's Disease Center	Kansas City	Kansas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Georgetown University	McLean	Virginia
United States	Veracity Neuroscience	Memphis	Tennessee
United States	Mount Sinai Hospital	New York	New York
United States	Riverside Neurology Specialists	Newport News	Virginia
United States	Headlands Research Orlando	Orlando	Florida
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Meridian Clinical Research	Raleigh	North Carolina
United States	Movement Disorder Center of Arizona	Scottsdale	Arizona
United States	Inland Northwest Research	Spokane	Washington
United States	USF Parkinson's Disease and Movement Disorders Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Scion NeuroStim

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 113 score - baseline day 29 score).	3 months
Other	Change from baseline in the Montreal Cognitive Assessment	a screening instrument used to facilitate the assessment of cognitive impairment.	3 months
Other	Change from baseline in the Oral Symbol Digit Modality Test	a brief and commonly used test to evaluate processing speed.	3 months
Other	Change from baseline in the Parkinson's Disease Sleep Scale 2	an assessment to quantify nocturnal sleep issues in Parkinson's disease.	3 months
Other	Change from baseline in Epworth Sleepiness Scale	a brief measure that is commonly used to assess daytime sleepiness.	3 months
Other	Change from baseline in the Parkinson Anxiety Scale	a brief questionnaire to detect anxiety severity in Parkinson's disease.	3 months
Other	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.	3 months
Other	Change from baseline in the Geriatric Depression Scale-15	a short questionnaire for assessing depression in older adults.	3 months
Other	Change from baseline in the MDS-NMS Non-Motor Fluctuations	a rater completed assessment evaluating fluctuations of non-motor symptoms in Parkinson's disease.	3 months
Other	Change from baseline in the Unified Parkinson's Disease Rating Scale Part IV	an assessment of complications of anti-Parkinsonian therapies.	3 months
Other	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.	3 months
Other	Change from baseline in the Zarit Burden Interview	measure of caregiving burden completed by caregivers.	3 months
Other	Change from baseline in the Patient Reported Outcome - Parkinson's Disease	a self-rating tool to assess symptom severity in Parkinson's disease.	3 months
Other	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.	3 months
Other	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.	3 months
Other	Change from baseline in EncephaLogTM finger tapping test	smart phone application providing a quantitative measure of bradykinesia.	3 months
Other	Change from baseline in EncephaLogTM 10 meter Timed Up and Go Test	smart phone application that measures gait and that provides indication of risk of falls in adults.	3 months
Other	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.	3 months
Other	Change from baseline in Hoehn & Yahr (H&Y)	staging tool describing the level of disability in Parkinson's disease.	3 months
Primary	Change from baseline in The International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) Total Score	The MDS-NMS is a 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 113 score - average of baseline scores from days 1 and 29)	3 months
Secondary	Change from baseline in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total score (Sum of Parts I, II and III)	The MDS- UPDRS is a multimodal scale consisting of four parts. Part I assesses non-motor aspects of experiences of daily living and consists of two components (range 0-52). Part II is a 13- item patient-reported assessment of motor aspects of experiences of daily living. Scores range between 0-52. Part III assesses motor signs of Parkinson's disease and is completed by the rater (range of 0-132). Part III consists of 33 scores based on 18 items. In all parts, higher scores indicate more symptoms. The range for the MDS-UPDRS total (sum of parts I, II and III) is 0-236. (baseline - week 12)	3 months
Secondary	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 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 113 score - average of baseline scores from days 1 and 29)	3 months
Secondary	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.	3 months
Secondary	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 113 score - average of baseline scores from days 1 and 29)	3 months
Secondary	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 113 score - average of baseline scores from days 1 and 29)	3 months