Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2025-12-17 @ 8:31 AM
Study NCT ID:
NCT04652583
Status:
None
Last Update Posted:
2022-01-11 00:00:00
First Post:
2020-11-10 00:00:00
Brief Title:
Auricular Muscle Zone Stimulation for Parkinson Disease
Sponsor:
Stoparkinson Healthcare Systems LLC
Organization:
Stoparkinson Healthcare Systems LLC
Study Overview
Official Title:
Auricular Muscle Zone Stimulation for Parkinson Disease (Earstim-PD)
Status:
None
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Earstim-PD
Brief Summary:
This study is a multi-center, prospective, randomized, double-blinded, sham-controlled, within-subject design, 3-treatment, 3-period cross-over study involving 38 subjects with Parkinson's Disease who have the wearing-off phenomenon on oral levodopa therapy. All participants will receive three treatments on different days, each with different stimulation conditions. All subjects will wear the Earstim device on the ear ipsilateral to the side of the body more affected by Parkinson's Disease for 120 minutes during each of the three treatment applications.
Detailed Description:
This study is a multi-center prospective randomized double-blinded sham-controlled within-subject design 3-treatment 3-period cross-over study involving 38 subjects with Parkinsons Disease who have the wearing-off phenomenon on oral levodopa therapy All participants will receive three treatments on different days each with different stimulation conditions All subjects will wear the Earstim device on the ear ipsilateral to the side of the body more affected by Parkinsons Disease for 120 minutes during each of the three treatment applications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None