Trials / Terminated
TerminatedNCT05987540
SHARPEN - Parkinson's Disease Dementia
Simple, Home-use Neurostimulation tReatment for Parkinson's Disease dEmeNtia
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Scion NeuroStim · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-05-08
- Primary completion
- 2025-02-24
- Completion
- 2025-02-24
- First posted
- 2023-08-14
- Last updated
- 2025-05-09
- Results posted
- 2025-05-09
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05987540. Inclusion in this directory is not an endorsement.