SHARPEN - Parkinson's Disease Dementia

Study Overview
=================
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.

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.

Official Title
-----------------
Simple, Home-use Neurostimulation tReatment for Parkinson's Disease dEmeNtia

Conditions
-----------------
Parkinson Disease Dementia

Intervention / Treatment
-----------------
* Device: Non-invasive brainstem stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Treatment<br>Investigational treatment mode (stimulation pattern) | Device: Non-invasive brainstem stimulation<br>* Study participants will self-administer  19-minute treatments twice daily in the home setting over 12 weeks using a non-invasive brainstem modulation device.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of neuromodulation device use in PDD population | The percentage of study participants reporting adverse events related to device use. | 12 weeks | 
| Feasibility of neuromodulation device use in PDD population | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of device use on cognition in people with mild/moderate PDD | 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. | 12 weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medical device, Non-Invasive Brain Stimulation, neuromodulation