STEM-Parkinson's Disease

  • STATUS
    Recruiting
  • End date
    May 28, 2023
  • participants needed
    218
  • sponsor
    Scion NeuroStim
Updated on 11 November 2022
dopamine
motor symptoms

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.

Details
Condition Parkinson Disease, Parkinson's Disease and Parkinsonism
Treatment Non-invasive brainstem stimulation
Clinical Study IdentifierNCT04797611
SponsorScion NeuroStim
Last Modified on11 November 2022

Eligibility

Yes No Not Sure

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 three years 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
Fully vaccinated from COVID-19 (at least 2 weeks from their final dose) with one of the current World Health Organization evaluated vaccines, prior to Screen
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 (i.e., are not yet 3 years removed from their first menopausal symptom), who are not abstinent or exclusively in same sex relationships must
Test negative for pregnancy as indicated by a negative urine pregnancy test
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
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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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