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

  • STATUS
    Recruiting
  • End date
    Mar 5, 2024
  • participants needed
    100
  • sponsor
    Emory University
Updated on 5 April 2022
chronic pain
transcranial direct current stimulation
pain relieving

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.

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.

Details
Condition Chronic Pain, Post Traumatic Stress Disorder (PTSD), Depression
Treatment tDCS
Clinical Study IdentifierNCT05254379
SponsorEmory University
Last Modified on5 April 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note