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SHARPEN - Parkinson's Disease Dementia

Recruiting
50 years of age
Both
Phase N/A

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Overview

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.

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

Study details

Parkinson Disease Dementia

NCT05987540

Scion NeuroStim

15 May 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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