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Neuromodulation Device

Brainstem Stimulation for Parkinson's Disease

N/A

Waitlist Available

Research Sponsored by Scion NeuroStim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

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

Must not have

Have active ear infections, or other significant ear problems

Are treated with a pump for continuous delivery of dopamine replacement medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a device that may help ease symptoms of Parkinson's disease without surgery.

Who is the study for?

Adults aged 18-85 with Parkinson's disease, responding to medications for at least a year, and able to follow the study plan. They need a partner who can participate, stable medication use during the trial, access to smart devices for data collection, and must be fully vaccinated against COVID-19.

What is being tested?

The trial is testing a non-invasive brainstem stimulation device's safety and effectiveness in treating Parkinson's symptoms. Participants are randomly assigned to receive either this new treatment or a placebo without knowing which one they're getting.

What are the potential side effects?

Potential side effects aren't specified but may include discomfort at the stimulation site or headaches due to the nature of brainstem stimulation. Other risks could relate to individual responses to non-invasive neuromodulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully vaccinated against COVID-19 with a WHO-approved vaccine.

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I've been on Parkinson's medication for over 3 years and it's working.

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I have been diagnosed with Parkinson's disease.

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I have been taking Parkinson's medication for over a year and it helps.

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I have trouble with daily activities like walking or dressing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active ear infection or significant ear problems.

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I use a pump for continuous dopamine medication.

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I have ongoing issues from a past surgery that still need medical attention.

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I have a neurological condition that might show symptoms similar to Parkinson's disease.

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I am not pregnant and do not plan to become pregnant during the study.

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I have had at least one ear infection each year for the last two years.

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I have not had eye surgery in the last 3 months or ear surgery in the last 6 months.

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I often fall down.

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I am not pregnant and agree to use birth control during the trial.

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I have had ringing in my ears for more than 3 months.

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I have had a heart attack, chest pain, stroke, or a mini-stroke in the last year.

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I am undergoing deep brain stimulation therapy.

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I have had a traumatic brain injury with lasting effects.

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I use a permanent or implanted hearing aid.

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I had an MRI-guided focused ultrasound treatment in the last year.

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I use apomorphine for sudden symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in The International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) Total Score

Secondary study objectives

Change from baseline in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II

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)

Change from baseline in the Clinical Global Impression-Improvement (CGI-I)

+2 more

Other study objectives

Change from baseline in EncephaLogTM 10 meter Timed Up and Go Test

Change from baseline in EncephaLogTM 3 meter Timed Up and Go Test

Change from baseline in EncephaLogTM finger tapping test

+16 more