38 Participants Needed

tDCS for Chronic Pain and PTSD

(Warriors Trial)

SR
BO
Overseen ByBarbara O Rothbaum, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You may need to stop taking certain medications to participate in this trial. Specifically, if you are currently using sodium channel blockers, calcium channel blockers, or N-Methyl-D-aspartate receptor antagonists, you might need to discontinue them. It's best to discuss your current medications with the trial team to see if any changes are necessary.

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with mild and temporary side effects like itching, tingling, and headaches. No serious or lasting injuries have been reported in over 33,200 sessions, even in potentially vulnerable groups like children and the elderly.12345

How is the tDCS treatment for chronic pain and PTSD different from other treatments?

tDCS (transcranial direct current stimulation) is unique because it is a noninvasive brain stimulation technique that modulates neural activity to relieve chronic pain, unlike traditional medications or invasive procedures. It targets specific brain areas to alter pain perception, offering a promising and safe alternative for pain management.678910

What data supports the effectiveness of the treatment for chronic pain and PTSD?

Research shows that transcranial direct current stimulation (tDCS) can help reduce chronic pain by changing brain activity in areas related to pain. Studies have found that tDCS can lower pain levels in patients with chronic pain and improve pain perception.678911

Who Is on the Research Team?

BO

Barbara O Rothbaum

Principal Investigator

Emory University

BW

Boadie W Dunlop, MD

Principal Investigator

Emory University

SR

Sheila Rauch, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for veterans aged 18-89 with chronic pain and PTSD who are treated at EHVP-IOP in Georgia or Florida. Participants must have a primary care provider, experience significant daily pain, and be willing to self-administer tDCS therapy. Exclusions include those with metal implants in the brain, pacemakers, certain medication use (like sodium/calcium channel blockers), history of brain tumor or surgery, seizures, stroke, pregnancy, non-English speakers.

Inclusion Criteria

I am willing to use the device on myself and follow the study's procedures.
Have an established PCP (Primary Care Provider) or pain management provider
I experience significant pain most days.
See 3 more

Exclusion Criteria

Pregnancy, if applicable
I have a history of seizures.
I have had a stroke in the past.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive transcranial direct current stimulation (tDCS) and cognitive-behavioral therapy (CBT) for chronic pain and PTSD over 2 weeks

2 weeks
10 sessions (remote)

Follow-up

Participants are monitored for changes in pain and PTSD symptoms using various outcome measures

12 months
Visits at months 1, 3, 6, 9, and 12

What Are the Treatments Tested in This Trial?

Interventions

  • Transcranial Direct Current Stimulation
Trial Overview The study tests transcranial direct current stimulation (tDCS) as a treatment for chronic pain and PTSD symptoms in veterans. It aims to see if this low-intensity electrical brain stimulation can reduce discomfort and improve mental health when combined with short-term therapy-focused treatment programs.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Transcranial Direct-Current Stimulation (tDCS)Experimental Treatment1 Intervention

Transcranial Direct Current Stimulation is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Transcranial Direct Current Stimulation for:
🇪🇺
Approved in European Union as Transcranial Direct Current Stimulation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

Wounded Warrior Project

Collaborator

Trials
1
Recruited
40+

Published Research Related to This Trial

In a study involving 80 healthy participants, high-definition transcranial direct current stimulation (HD-tDCS) did not significantly reduce pain intensity from nerve growth factor-induced pain, indicating limited efficacy in acute pain relief.
However, HD-tDCS was effective in reducing the facilitation of temporal summation of pain in participants experiencing induced pain, suggesting that its benefits may be more pronounced in individuals with sensitized central pain mechanisms.
Modulation of central pain mechanisms using high-definition transcranial direct current stimulation: A double-blind, sham-controlled study.Kold, S., Graven-Nielsen, T.[2023]
Five consecutive days of anodal transcranial direct current stimulation (tDCS) over the primary motor cortex significantly improved pain ratings in patients with chronic pain, with effects lasting three to four weeks post-treatment.
The study showed that anodal tDCS decreased intracortical inhibition, indicating enhanced cortical excitability, and no severe adverse effects were reported, suggesting it is a safe treatment option.
Anodal transcranial direct current stimulation of the motor cortex ameliorates chronic pain and reduces short intracortical inhibition.Antal, A., Terney, D., Kühnl, S., et al.[2022]
Transcranial direct-current stimulation (tDCS) significantly reduced both mechanical and thermal hyperalgesia in a rat model of orofacial inflammatory pain, showing effectiveness in pain management up to 7 days post-treatment.
The treatment with tDCS led to increased levels of neurotrophic factors (BDNF and NGF) and anti-inflammatory cytokines (IL-6 and IL-10) in the brainstem, suggesting a mechanism of action that involves modulation of neuroplasticity and inflammation.
Transcranial direct-current stimulation reduces nociceptive behaviour in an orofacial pain model.Scarabelot, VL., de Oliveira, C., Medeiros, LF., et al.[2019]

Citations

Modulation of central pain mechanisms using high-definition transcranial direct current stimulation: A double-blind, sham-controlled study. [2023]
Anodal transcranial direct current stimulation of the motor cortex ameliorates chronic pain and reduces short intracortical inhibition. [2022]
Transcranial direct-current stimulation reduces nociceptive behaviour in an orofacial pain model. [2019]
Does anodal transcranial direct current stimulation modulate sensory perception and pain? A meta-analysis study. [2022]
Modulatory effects of anodal transcranial direct current stimulation on perception and pain thresholds in healthy volunteers. [2015]
Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]
A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Safety of transcranial direct current stimulation in healthy participants. [2021]
Methods and strategies of tDCS for the treatment of pain: current status and future directions. [2023]
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