Clinical trial NCT05254379: Transcranial Direct Current Stimulation Treatment for Warriors Experiencing Chronic Pain
Official title: Transcranial Direct Current Stimulation Treatment for Warriors Experiencing Chronic Pain (tDCS for Warriors)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Post Traumatic Stress Disorder (PTSD)
Depression
Keywords: Transcranial direct current stimulation (tDCS)
Veterans
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Wounded Warrior Project
First posted: 2022-02-24
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
  * Numbness
  * Tingling
  * Weakness
* Medical contraindications:

  * Current use of sodium channel blockers

    * Lidocaine (OTC/transdermal delivery is ok)
    * Mexiletine
    * Amitriptyline; other tricyclic antidepressants
    * Anti-epileptic medications
* Phenytoin, carbamazepine, lamotrigine, oxcarbazepine, rufinamide, lacosamide and eslicarbazepine acetate

  * Current use of calcium channel blockers
  * Current use of N-Methyl-D-aspartate receptor antagonists

    * Ketamine
    * Dextromethorphan
    * Felbamate
  * History of brain surgery
  * History of brain tumor
  * History of seizure disorder
  * History of stroke
  * Intracranial metal implantation
* Adults unable to consent
* Individuals who are not yet adults
* Prisoners
* Non-English speaking

Primary outcomes:
measure: Changes in Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: Intake, Days 1,3, 5 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up
Secondary outcomes:
measure: Changes in PROMIS 3a pain intensity
timeFrame: Day 1 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up
measure: Changes in PROMIS 8a pain interference
timeFrame: Day 1 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up
measure: Changes in PTSD Checklist- PCL-5
timeFrame: Days 1 through 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up
measure: Changes in BDNF in saliva
timeFrame: Days 2, 5 and 11 of the intervention
measure: Changes in BDNF in blood
timeFrame: Days 2, 5 and 11 of the intervention
measure: PTSD Checklist - Stressor-Specific Version (PCL-5
timeFrame: Intake, Days 1,3, 5 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up
measure: Patient Health Questionnaire- 9 (PHQ-9)
timeFrame: Intake, Days 1,3, 5 and 12 of intervention
measure: Change in Clinician Administered PTSD Scale-5 (CAPS5)
timeFrame: Intake, Day 1 of treatment and month 3 follow up
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Division of Psychiatry
state: Georgia
Study officials:
affiliation: Emory University
name: Sheila Rauch, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Barbara O Rothbaum
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Boadie W Dunlop, MD
role: PRINCIPAL_INVESTIGATOR
References: