Transcranial Direct Current Stimulation Treatment for Warriors Experiencing Chronic Pain

NCT05254379 | Completed DMC FDA Device

• 1 other identifier: STUDY00003899
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Transcranial direct current stimulation (tDCS); Veterans

Outcome Measures

Primary Outcomes (1)

• Changes in Defense and Veterans Pain Rating Scale (DVPRS)

  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.

  Intake, Days 1,3, 5 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up

Secondary Outcomes (8)

• 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

• Changes in BDNF in saliva

  Days 2, 5 and 11 of the intervention

• Changes in BDNF in blood

  Days 2, 5 and 11 of the intervention

Study Arms (1)

Transcranial Direct-Current Stimulation (tDCS)

EXPERIMENTAL

Participants will be assigned to tDCS intervention. Starting Day 1 of EHVP-IOP, remote-based tDCS will be administered with a constant current intensity for 20 min per session for up to 10 sessions over 2 weeks (one session per day) using a Soterix 1x1 tDCS mini-CT Stimulator with headgear and saline-soaked surface sponge electrodes. Therapy sessions will be performed over Zoom. With the exception of day one when the session will occur on its own, the sessions will occur within one hour of the start of the daily therapy session.

Device: tDCS

Interventions

tDCS DEVICE

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.

Transcranial Direct-Current Stimulation (tDCS)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Wounded Warrior Project: collaborator

Study Sites (1)

Emory Division of Psychiatry

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Chronic Pain; Stress Disorders, Post-Traumatic; Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Sheila Rauch, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

• Barbara O Rothbaum

  Emory University

  PRINCIPAL INVESTIGATOR

• Boadie W Dunlop, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 24, 2022
• Study Start: March 4, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)