Transcranial Direct Current Stimulation Treatment for Warriors Experiencing Chronic Pain — Warriors  

Depression Clinical Trial

Official title: Transcranial Direct Current Stimulation Treatment for Warriors Experiencing Chronic Pain (tDCS for Warriors)

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 subject's 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. ;

Related Conditions & MeSH terms

• Chronic Pain
• Depression
• Post Traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT05254379
• Study type: Interventional
• Source: Emory University
• Contact: Sheila Rauch, PhD
• Phone: 404-778-1428
• Email: sheila.a.m.rauch@emory.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2022
• Completion date: June 2025