Transcranial Direct Current Stimulation Treatment for Warriors Experiencing Chronic Pain (tDCS for Warriors)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Emory University
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Changes in Defense and Veterans Pain Rating Scale (DVPRS)
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
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.
Investigators
Sheila Rauch
Professor
Emory University
Eligibility Criteria
Inclusion Criteria
- •Male or Female, 18 -89 years old
- •Treated on site for EHVP IOP
- •For long-term follow-up, must live in Georgia or Florida
- •Eligible for EHVP-IOP PTSD or Unified Protocol tracks
- •Willing to self-administer tDCS and complete the measures
- •DVPRS pain intensity of 4 or more for most of the day at least 3 days per week
- •Have an established PCP (Primary Care Provider) or pain management provider
Exclusion Criteria
- •Implanted pacemaker
- •Seizure Disorder
- •Pregnancy, if applicable
- •Any new onset of the following:
- •Balance problems
- •Difficulty walking
- •Bladder incontinence
- •Bowel incontinence
- •Medical contraindications:
- •Current use of sodium channel blockers
Outcomes
Primary Outcomes
Changes in Defense and Veterans Pain Rating Scale (DVPRS)
Time Frame: Intake, Days 1,3, 5 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up
The DVPRS assesses chronic pain using a visual analogue scale of 0 to 10 including general level of pain, and assessment of interference with daily activities, mood, sleep, and stress. It is widely used in clinical care and research and has demonstrated reliability and validity within the military and Veteran population. This is a clinical measure collected per standard of care at intake. However, this measure will be collected for research purposes at additional timepoints, include each tDCS session, 1-10, and all follow-up visits.
Secondary Outcomes
- Changes in BDNF in blood(Days 2, 5 and 11 of the intervention)
- Change in Clinician Administered PTSD Scale-5 (CAPS5)(Intake, Day 1 of treatment and month 3 follow up)
- Changes in BDNF in saliva(Days 2, 5 and 11 of the intervention)
- Changes in PROMIS 3a pain intensity(Day 1 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up)
- Changes in PROMIS 8a pain interference(Day 1 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up)
- Changes in PTSD Checklist- PCL-5(Days 1 through 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up)
- PTSD Checklist - Stressor-Specific Version (PCL-5(Intake, Days 1,3, 5 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up)
- Patient Health Questionnaire- 9 (PHQ-9)(Intake, Days 1,3, 5 and 12 of intervention)