Ignite Creation Date:
2024-05-06 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05254379
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2022-02-15
Brief Title:
Transcranial Direct Current Stimulation Treatment for Warriors Experiencing Chronic Pain
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Transcranial Direct Current Stimulation Treatment for Warriors Experiencing Chronic Pain tDCS for Warriors
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:
Warriors
Brief Summary:
The Veteran population has been known to deal with co-morbid chronic pain and PTSD As a result they use healthcare services at a higher rate than those Veterans with pain or PTSD alone which leads to an amplified burden on healthcare systems
tDCS is a painless brain stimulation treatment that uses direct electrical currents at a constant low-intensity level to stimulate specific parts of the brain and help modulate neuronal activity This study hypothesizes that our short-term therapy-focused treatment program coupled with tDCS administrations will aid in the reduction of chronic pain and PTSD symptoms Secondly the investigators intend to examine any relationships between BDNF reduction in reported pain and PTSD and related mental health symptoms Subjects will be identified from the Emory Healthcare Veterans Program EHVP-IOP Veterans and Service members seeking psychiatric treatment for mental health issues including PTSD
tDCS is a painless brain stimulation treatment that uses direct electrical currents at a constant low-intensity level to stimulate specific parts of the brain and help modulate neuronal activity This study hypothesizes that our short-term therapy-focused treatment program coupled with tDCS administrations will aid in the reduction of chronic pain and PTSD symptoms Secondly the investigators intend to examine any relationships between BDNF reduction in reported pain and PTSD and related mental health symptoms Subjects will be identified from the Emory Healthcare Veterans Program EHVP-IOP Veterans and Service members seeking psychiatric treatment for mental health issues including PTSD
Detailed Description:
The Veteran population has been known to deal with co-morbid chronic pain and PTSD As a result they use healthcare services at a higher rate than those Veterans with pain or PTSD alone which leads to an amplified burden on healthcare systems In the process of seeking relief and treatment in the healthcare systems Veterans may use opioid medications to treat chronic pain which puts them at risk for harmful consequences
This study will be an open trial providing a non-opioid self-administered effective pain intervention as part of an effective mental health treatment program A transcranial direct current stimulation tDCS device will be utilized in combination with a cognitive-behavioral therapy CBT focused intensive outpatient program IOP Additionally blood and saliva will be collected during this study to perform brain derived neurotropic factor BDNF assays comparing outcomes from specific visits pre-treatment tx mid-tx and post-tx
The study will take place at the Brain Health Center BHC located at 12 Executive Park in the Veterans Program Department
Subjects will be identified from the Emory Healthcare Veterans Program EHVP-IOP Veterans and Service members seeking psychiatric treatment for mental health issues Incoming patients will be screened for this study and consented prior to the start of their treatment program participation An electronic consent will be conducted using the REDCap e-Consent framework A partial waiver of consent is requested to be able to review identifiable information to determine a potential subjects eligibility status
This study hypothesizes that our short-term therapy-focused treatment program coupled with tDCS administrations will aid in the reduction of chronic pain Secondly we intend to examine reductions in PTSD and related mental health symptoms and any relationships between BDNF reduction in reported pain and PTSD and related mental health symptoms
This study will be an open trial providing a non-opioid self-administered effective pain intervention as part of an effective mental health treatment program A transcranial direct current stimulation tDCS device will be utilized in combination with a cognitive-behavioral therapy CBT focused intensive outpatient program IOP Additionally blood and saliva will be collected during this study to perform brain derived neurotropic factor BDNF assays comparing outcomes from specific visits pre-treatment tx mid-tx and post-tx
The study will take place at the Brain Health Center BHC located at 12 Executive Park in the Veterans Program Department
Subjects will be identified from the Emory Healthcare Veterans Program EHVP-IOP Veterans and Service members seeking psychiatric treatment for mental health issues Incoming patients will be screened for this study and consented prior to the start of their treatment program participation An electronic consent will be conducted using the REDCap e-Consent framework A partial waiver of consent is requested to be able to review identifiable information to determine a potential subjects eligibility status
This study hypothesizes that our short-term therapy-focused treatment program coupled with tDCS administrations will aid in the reduction of chronic pain Secondly we intend to examine reductions in PTSD and related mental health symptoms and any relationships between BDNF reduction in reported pain and PTSD and related mental health symptoms
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