Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06203717
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-01
First Post:
2023-11-08
Brief Title:
Cranial Electrotherapy Stimulation Piloting a Road to PTSD Prevention in First Responders
Sponsor:
Butler Hospital
Organization:
Butler Hospital
Study Overview
Official Title:
Cranial Electrotherapy Stimulation Piloting a Road to PTSD Prevention in First Responders
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
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:
The goal of this study is to test whether active duty firefighters find it possible and suitable to do cranial electrotherapy stimulation CES at home and test whether CES influences measures of stress The main questions it aims to answer are
is CES feasible and acceptable in a population of firefighters and
does CES changes feelings of fatigue anxiety and brain connectivity in firefighters
Participants will
complete four weeks of CES at home and
complete daily assessments of fatigue and anxiety and maybe asked to
complete an MRI scan before and after CES and
wear a device to measure their heart rate and sleep quality
is CES feasible and acceptable in a population of firefighters and
does CES changes feelings of fatigue anxiety and brain connectivity in firefighters
Participants will
complete four weeks of CES at home and
complete daily assessments of fatigue and anxiety and maybe asked to
complete an MRI scan before and after CES and
wear a device to measure their heart rate and sleep quality
Detailed Description:
Despite an urgent need for interventions that can prevent the development of posttraumatic stress disorder PTSD in firefighter first responders who due to the nature of their occupation are at ultrahigh risk for PTSD and its profound consequences current preventative approaches suffer from low rates of efficacy or difficulties with implementation Cranial electrotherapy stimulation CES a noninvasive brain stimulation technique that is FDA approved for treatment of anxiety insomnia and depression offers substantial promise as a proactive preventative intervention for PTSD because of its hypothesized ability to reestablish homeostasis a process that becomes dysregulated in individuals who develop PTSD The proposed study is an administrative supplement that combines the unique strengths and knowledge of a complimentary team of scientists from two distinct Centers of Biomedical Research Excellence to test whether four weeks of CES is feasible and acceptable in firefighters as well as obtain early signal of CES efficacy to change subjective and objective indices of homeostatic functioning to allow a long-term collaboration with the ultimate goal to develop a safe effective and easily deployable intervention to prevent PTSD in first responders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None