NCT05254379

Transcranial Direct Current Stimulation Treatment for Warriors Experiencing Chronic Pain

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Chronic Pain
• Post Traumatic Stress Disorder (PTSD)
• Depression

Interventions

Type	Name	Description
DEVICE	tDCS	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. Participants will receive a series of tDCS treatments during the Intensive Outpatient Program (IOP) coupled with blood and saliva collections. Participants will administer a stimulation session via the Soterix 1x1 tDCS mini-CT Stimulator, after being provided a single-use code to unlock the device by the research staff once proper contact quality is achieved. After the participant enters the unlock code, the screen on the device will show a timer that counts down the minutes until the end of the session. After 20 min, the device will turn off automatically and the study staff will instruct the participant to remove the headset and discard the sponges and to store safely all materials for the next session.

Timeline

• Start date: 2022-03-04
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2022-02-24
• Last updated: 2025-09-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study