SHARPEN - Parkinson's Disease Dementia
Purpose
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
- Parkinson Disease Dementia
Eligibility
- Eligible Ages
- Over 50 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants with clinical diagnosis of probable PDD - Positive response to levodopa and have been treated with levodopa-based therapies for minimum of one years - Participants must be willing and able to comply with all study requirements - 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 - 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
- Participant anticipates being unable to attend all visits and complete all study activities during the trial - Women of child-bearing potential who are pregnant or plan to become pregnant during the course of the trial - Has experienced a heart attack, angina, or stroke within the past 12 months or transient ischemic attack (TIA) within the past 6 months - Are being treated with another neurostimulation device - Demonstrate suicidality - Have been previously diagnosed with either central vestibular dysfunction (lifetime) or have experienced l peripheral vestibular dysfunction within the last 12 months. - Have active ear infections, perforated tympanic membrane or labyrinthitis, as identified by a general ear examination - Have a recent history of frequent ear infections (≥ 1 per year over the past two years) - Have a cochlear implant, myringotomy tubes or hearing aids that cannot be easily/reliably removed for treatment - Have chronic tinnitus
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Investigational Treatment |
Investigational treatment mode (stimulation pattern) |
|
Recruiting Locations
University of Kansas Medical Center-Parkinson's Disease Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
More Details
- Status
- Recruiting
- Sponsor
- Scion NeuroStim
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.