SHARPEN - Parkinson's Disease Dementia
Study Details
Study Description
Brief Summary
The purpose of this single arm study is to evaluate the feasibility and safety of treatments with a non-invasive neuromodulation device in adults diagnosed with mild/moderate Parkinson's disease dementia (PDD). A non-invasive device is a device that stays outside of the body and is not implanted and does not penetrate the skin.
Neuromodulation means that the device stimulates activity in the brain.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Up to 12 participants will self-administer treatments twice daily in the home setting over a period of 12 weeks. There are 4 study center visits, including an eligibility visit, as well as multiple phone calls.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Investigational Treatment Investigational treatment mode (stimulation pattern) |
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.
|
Outcome Measures
Primary Outcome Measures
- Safety of neuromodulation device use in PDD population [12 weeks]
The percentage of study participants reporting adverse events related to device use.
- Feasibility of neuromodulation device use in PDD population [12 weeks]
Retention rate or the percent of participants that complete the secondary endpoint at all study visits in the study protocol and treatment adherence rate during the 12-week treatment period.
Secondary Outcome Measures
- Effects of device use on cognition in people with mild/moderate PDD [12 weeks.]
Change in the Montreal Cognitive Assessment (MoCA) between the baseline and end of treatment visit (Day 84) after 12 weeks of treatment. The MoCA is a cognitive assessment where scores range from zero to 30, with a higher score indicating a better cognitive function.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants with clinical diagnosis of probable PDD
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Positive response to levodopa and have been treated with levodopa-based therapies for minimum of one years
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Participants must be willing and able to comply with all study requirements
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Participants must expect that the participant will be able to remain on a stable regimen of concomitant therapies used for the management of PD and not to introduce new medications used to treat PD (motor or non-motor symptoms) during the study
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Participant must have a study partner (defined as someone who sees the participant for more than three hours a day, 5x per week) that is willing to consent and participate in the trial.
Exclusion Criteria:
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Participant anticipates being unable to attend all visits and complete all study activities during the trial
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Women of child-bearing potential who are pregnant or plan to become pregnant during the course of the trial
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Has experienced a heart attack, angina, or stroke within the past 12 months or transient ischemic attack (TIA) within the past 6 months
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Are being treated with another neurostimulation device
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Demonstrate suicidality
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Have been previously diagnosed with either central vestibular dysfunction (lifetime) or have experienced l peripheral vestibular dysfunction within the last 12 months.
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Have active ear infections, perforated tympanic membrane or labyrinthitis, as identified by a general ear examination
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Have a recent history of frequent ear infections (≥ 1 per year over the past two years)
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Have a cochlear implant, myringotomy tubes or hearing aids that cannot be easily/reliably removed for treatment
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Have chronic tinnitus
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Scion NeuroStim
- National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SNS-PD-004