Viewing Study NCT04598828



Ignite Creation Date: 2024-05-06 @ 3:19 PM
Last Modification Date: 2024-10-26 @ 1:47 PM
Study NCT ID: NCT04598828
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-06-27
First Post: 2020-10-16

Brief Title: Use of a Non-Invasive Brainstem Neuromodulation Device to Improve Neurovascular Status in Parkinsons Disease
Sponsor: Wake Forest University Health Sciences
Organization: Wake Forest University Health Sciences

Study Overview

Official Title: Using Time Varying Non-Invasive Neuromodulation to Improve Neurovascular Status in Parkinsons Disease
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-06
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: None
Brief Summary: This study is a single-site double-blinded randomized clinical trial designed to elucidate mechanisms of action for symptomatic benefits observed in Parkinsons disease PD
Detailed Description: Patients treating twice daily using a non-invasive brainstem modulation device Study participants will self-administer treatments in the home setting over a period of 12 weeks Changes in cerebral blood flow perfusion cerebrovascular reactivity and functional connectivity between the pre-treatment baseline and the end of the treatment period will be monitored and compared to changes in validated standardized clinical measures of motor and non-motor symptoms in PD

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