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tDCS for Chronic Pain and PTSD (Warriors Trial)

N/A

Waitlist Available

Led By Sheila Rauch, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Treated on site for EHVP IOP

DVPRS pain intensity of 4 or more for most of the day at least 3 days per week

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intake, days 1,3, 5 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new painless brain stimulation treatment to see if it can help Veterans with chronic pain and PTSD. The treatment is called tDCS and stands for transcranial direct current stimulation. The study will also examine any relationships between this treatment and reductions in symptoms of PTSD and related mental health issues.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of tDCS may include mild skin irritation under the electrode site, tingling sensations during administration, fatigue after treatment sessions, headaches or light-headedness. Serious side effects are rare but could involve worsening depression or mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am receiving treatment for high eye pressure at this facility.

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I experience significant pain most days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have new issues with balance, walking, bladder or bowel control, or I feel numbness, tingling, or weakness.

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I am not currently taking specific heart, seizure, or certain pain and mood medications.

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I have a history of seizures.

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I have had a stroke in the past.

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I am under the age of 18.

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I have had brain surgery in the past.

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I am unable to give consent for medical procedures.

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I have had a brain tumor.

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I have a seizure disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intake, days 1,3, 5 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intake, days 1,3, 5 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and intake, days 1,3, 5 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Defense and Veterans Pain Rating Scale (DVPRS)

Secondary study objectives

Change in Clinician Administered PTSD Scale-5 (CAPS5)

Brain-derived neurotrophic factor

Changes in BDNF in saliva

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transcranial Direct-Current Stimulation (tDCS)Experimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

tDCS

2017

Completed Phase 2

~630

0 / 11Eligibility criteria met