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SHARPEN - Parkinson's Disease Dementia (SHARPEN)

Primary Purpose

Parkinson Disease Dementia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-invasive brainstem stimulation
Sponsored by
Scion NeuroStim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease Dementia focused on measuring medical device, Non-Invasive Brain Stimulation, neuromodulation

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Investigational Treatment

    Arm Description

    Investigational treatment mode (stimulation pattern)

    Outcomes

    Primary Outcome Measures

    Safety of neuromodulation device use in PDD population
    The percentage of study participants reporting adverse events related to device use.
    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    July 26, 2023
    Last Updated
    August 3, 2023
    Sponsor
    Scion NeuroStim
    Collaborators
    National Institute of Neurological Disorders and Stroke (NINDS)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05987540
    Brief Title
    SHARPEN - Parkinson's Disease Dementia
    Acronym
    SHARPEN
    Official Title
    Simple, Home-use Neurostimulation tReatment for Parkinson's Disease dEmeNtia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2024 (Anticipated)
    Study Completion Date
    November 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Scion NeuroStim
    Collaborators
    National Institute of Neurological Disorders and Stroke (NINDS)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease Dementia
    Keywords
    medical device, Non-Invasive Brain Stimulation, neuromodulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Investigational Treatment
    Arm Type
    Experimental
    Arm Description
    Investigational treatment mode (stimulation pattern)
    Intervention Type
    Device
    Intervention Name(s)
    Non-invasive brainstem stimulation
    Intervention Description
    Study participants will self-administer ~19-minute treatments twice daily in the home setting over 12 weeks using a non-invasive brainstem modulation device.
    Primary Outcome Measure Information:
    Title
    Safety of neuromodulation device use in PDD population
    Description
    The percentage of study participants reporting adverse events related to device use.
    Time Frame
    12 weeks
    Title
    Feasibility of neuromodulation device use in PDD population
    Description
    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.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Effects of device use on cognition in people with mild/moderate PDD
    Description
    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.
    Time Frame
    12 weeks.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kara Richardson
    Phone
    984-884-1020
    Email
    krichardson@scionneurostim.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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