SHARPEN - Parkinson's Disease Dementia

Parkinson Disease Dementia Clinical Trial

— SHARPEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05987540
• Other study ID #: SNS-PD-004
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2024
• Est. completion date: November 1, 2025

Study information

• Verified date: May 2024
• Source: Scion NeuroStim
• Contact: Kara Richardson
• Phone: 984-884-1020
• Email: krichardson[@]scionneurostim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Parkinson Disease
• Parkinson Disease Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	Parkinson's Disease and Movement Disorder Center of Boca Raton	Boca Raton	Florida
United States	University of Kansas Medical Center-Parkinson's Disease Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Scion NeuroStim	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of neuromodulation device use in PDD population	The percentage of study participants reporting adverse events related to device use.	12 weeks
Primary	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	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.