Non-Invasive Brainstem Modulation for the Treatment of Non-Motor Symptoms in Parkinson’s Disease: A Randomized Controlled Trial (RCT) and an Open Label Extension (OLE) Study

  • STATUS
    Recruiting
  • End date
    Oct 31, 2024
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Updated on 10 November 2022
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Summary

The purpose of this research is to understand how a non-invasive neuromodulation device affects adults diagnosed with Parkinson’s disease (PD).  A non-invasive device is a device that stays outside of the body. It is not implanted and does not penetrate the skin. Neuromodulation means that the device stimulates activity in the brain. Your participation in this study will last approximately one year.  The first 4 months will be a randomized portion of the trial used to evaluate the study device’s safety and effectiveness. You will be randomly assigned by chance (like the flip of a coin) to one of two study treatment groups. Each study treatment group will use the same study device but will receive a different study treatment mode (neurostimulation pattern).  The remaining 8 months will be an open label extension (OLE). This means that everyone participating in the OLE will be switched to the study treatment mode that has shown to be safe and the most effective. You cannot participate in the OLE unless you have participated in the RCT. 

Description

In this study, we will test the safety and the effectiveness of neuromodulation in treating non-motor symptoms in people with PD as well as determine if this neuromodulation study treatment is effective for improving motor symptoms and/or for improving overall quality of life for people with PD.   The study device consists of a headset, which looks like a music earphone headset, and a base station that powers the headset. The headset has metallic earpieces that fit into the ear canals. When activated, the study device will deliver a prescribed stimulation pattern for approximately 20 minutes. You will use the study device at home, twice daily, at least one hour apart.

Details
Condition Parkinson Disease
Clinical Study IdentifierTX310244
Last Modified on10 November 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Adult participants (aged 18 – 85 years) that have been diagnosed with Parkinson’s disease by a doctor
Participants must have symptoms of Parkinson’s that do not affect movement called non-motor symptoms, such as thinking, mood, and sleep issues. Participants can also have motor symptoms
Participant has a friend, family member, or caregiver who can also participant in the study that you see at least an hour a day for 3 days in a week
Participants must have been treated with Parkinson’s disease medications, called dopamine replacement therapy (DRT) for at least 3 years

Exclusion Criteria

Are receiving deep brain stimulation therapy
Have dementia
Have a cochlear implant or hearing aids that cannot be removed
Are not on stable medications for their Parkinson’s symptoms
Have frequent ear infections or frequent falls
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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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