STEM-Parkinson's Disease

Scion NeuroStim

Status: Active, not recruiting

Conditions: Parkinson Disease; Parkinson's Disease and Parkinsonism

Treatments: Device: Non-invasive brainstem stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT04797611

SNS-PD-002

Details and patient eligibility

About

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.

Full description

Up to 184 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.

Enrollment: 188 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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188 participants in 2 patient groups

Investigational Treatment 1

Other group

Description:

Investigational treatment mode (stimulation pattern) 1

Treatment:

Device: Non-invasive brainstem stimulation

Investigational Treatment 2

Other group

Description:

Investigational treatment mode (stimulation pattern) 2

Treatment:

Device: Non-invasive brainstem stimulation