Transcranial Direct Current Stimulation Treatment for Warriors Experiencing Chronic Pain

NCT ID: NCT05254379

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-04
• Study Completion Date: 2025-05-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transcranial Direct-Current Stimulation (tDCS)

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.

Group Type: EXPERIMENTAL

tDCS

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wounded Warrior Project

UNKNOWN

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Sheila Rauch

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheila Rauch, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Barbara O Rothbaum

Role: PRINCIPAL_INVESTIGATOR

Emory University

Boadie W Dunlop, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Division of Psychiatry

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00003899

Identifier Type: -

Identifier Source: org_study_id