tDCS for Chronic Pain and PTSD

(Warriors Trial)

Overseen By Barbara O Rothbaum, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must not be taking: Sodium blockers, Calcium blockers

Disqualifiers: Seizure disorder, Brain surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment called transcranial Direct Current Stimulation (tDCS) to reduce chronic pain and PTSD symptoms in Veterans. tDCS is a non-invasive method using mild electrical currents to stimulate specific brain areas. The trial aims to determine if combining tDCS with short-term therapy can improve symptoms. Veterans experiencing frequent and significant pain and PTSD, who receive treatment through the Emory Healthcare Veterans Program, may be suitable candidates.

As an unphased trial, this study provides Veterans the chance to explore innovative treatment options that could enhance their quality of life.

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.

What prior data suggests that this tDCS treatment is safe for chronic pain and PTSD?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe for people. In studies with patients experiencing chronic pain, this treatment was well-tolerated. Few reports of side effects indicate that tDCS is a low-risk option. Repeated tDCS sessions do not appear riskier than sham (inactive) treatments. Other research supports that tDCS is safe and may help reduce pain in conditions like fibromyalgia, which causes widespread pain. Overall, current evidence suggests tDCS is a safe method for managing chronic pain and other conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike most treatments for chronic pain and PTSD that often rely on medications such as opioids or antidepressants, Transcranial Direct Current Stimulation (tDCS) uses a non-invasive technique applying a low electrical current to the brain. This method is unique because it targets brain activity directly, potentially offering relief without the side effects linked to medication. Additionally, tDCS can be administered remotely over Zoom, making it more accessible and convenient for patients. Researchers are excited about tDCS as it represents a novel approach that might provide quicker and more sustainable relief for those suffering from these conditions.

What evidence suggests that tDCS is effective for chronic pain and PTSD?

Research shows that transcranial direct current stimulation (tDCS), which participants in this trial will receive, can help reduce long-lasting pain and increase pain tolerance. Studies have found it useful for managing various types of chronic pain, and it can be safely used at home. For PTSD, applying tDCS to certain brain areas effectively reduces symptoms, with benefits seen both immediately and over time. Overall, tDCS appears promising for easing symptoms of both chronic pain and PTSD. ^{2 6 7 8 9}

Who Is on the Research Team?

Sheila Rauch, PhD

Principal Investigator

Emory University

Barbara O Rothbaum

Principal Investigator

Emory University

Boadie W Dunlop, MD

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.

Exclusion Criteria

Pregnancy, if applicable

I have a history of seizures.

I have had a stroke in the past.

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?

Group I: Transcranial Direct-Current Stimulation (tDCS) Experimental Treatment 1 Intervention

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.

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:

• Chronic pain management
• Depression
• Anxiety

Approved in European Union as Transcranial Direct Current Stimulation for:

• Chronic pain management
• Neurological rehabilitation

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct-current stimulation reduces nociceptive behaviour in an orofacial pain model. Scarabelot, VL., de Oliveira, C., Medeiros, LF., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

Anodal transcranial direct current stimulation (a-tDCS) applied to the primary motor cortex significantly increases sensory and pain thresholds in healthy individuals, with effect sizes of 22.19% and 19.28%, respectively.

In patients with chronic pain, a-tDCS applied to the primary motor cortex and dorsolateral prefrontal cortex resulted in a significant reduction in pain levels, with an average decrease in pain scores of 14.9% and 19.3%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does anodal transcranial direct current stimulation modulate sensory perception and pain? A meta-analysis study. Vaseghi, B., Zoghi, M., Jaberzadeh, S.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of central pain mechanisms using high-definition transcranial direct current stimulation: A double-blind, sham-controlled study. Kold, S., Graven-Nielsen, T.[2023]

Transcranial direct current stimulation (tDCS) is a promising and safe noninvasive technique for managing chronic pain, with effective results observed when targeting the primary motor cortex and prefrontal cortex.

Future strategies to enhance tDCS effects include high-intensity stimulation, transcutaneous spinal stimulation, and home-based devices, which aim to improve accessibility and potentially increase the neuroplastic benefits of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods and strategies of tDCS for the treatment of pain: current status and future directions. Pacheco-Barrios, K., Cardenas-Rojas, A., Thibaut, A., et al.[2023]

Transcranial direct current stimulation (tDCS) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

A systematic review of 64 studies involving 2262 participants found that transcranial direct current stimulation (tDCS) has a low dropout rate (6% for active and 7.2% for sham), indicating good acceptability among participants.

Despite the low dropout rates, many studies inadequately reported adverse events (AEs), highlighting a need for improved guidelines to standardize AE reporting in tDCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Aparício, LVM., Guarienti, F., Razza, LB., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12485468/

Effects of Transcranial Direct Current Stimulation on pain and ... tDCS appears to decrease pain intensity and modulate thresholds for pressure and heat pain, as well as enhance tolerance to heat and cold.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11590159/

The effectiveness of home-based transcranial direct current ... Low to moderate certainty evidence suggests that home-based self-administered tDCS is a safe and effective tool for managing various types of chronic pain.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0361923019306550

Transcranial direct current stimulation (tDCS) for post- ... Our results revealed that active tDCS over the bilateral DLPFC was effective in relieving the severity of PTSD symptoms at post-test and follow-up.

4. nature.com nature.com/articles/s41398-024-03053-0

Immediate and long-term efficacy of transcranial direct ... Overall, the results of meta-analysis indicated that tDCS had a high effect in improving specific symptoms (SMD = −0.73, 95% CI: −1.09 to −0.37) ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05863494

Transcranial Direct Current Stimulation and Chronic Pain The overarching goal of this project is to apply transcranial direct current stimulation (tDCS) as an alternative to opioids for the reduction in chronic pain.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41099741/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=1V_PRf-wigmlSOdGL4O14HK_uFT0-zGOQAUYmbbdNXpGhXmkV7&fc=None&ff=20251029063023&v=2.18.0.post22+67771e2

A Systematic Review of Reporting Adverse Effects ... In the present form of reporting AEs of tDCS in clinical studies involving patients with chronic pain, this procedure seems to be safe.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1935861X17309555

Safety of repeated sessions of transcranial direct current ... Little evidence was found to suggest that repeated sessions of active tDCS pose increased risk to participants compared to sham tDCS within the limits of ...

8. epain.org epain.org/journal/view.html?uid=1917&vmd=Full

Effects of Transcranial Direct Current Stimulation on pain ... tDCS is a risk-free treatment that may help FM patients experience less severe pain. Cai et al. [22], USA, China, 2021, SR + MA of RCTs ...

9. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14887

The safety and feasibility of transcranial direct current ... We found transcranial direct current stimulation combined with exercise therapy was safe and feasible for patients with cervicogenic headache; ...