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tDCS for Chronic Pain and PTSD (Warriors Trial)
N/A
Recruiting
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
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
Warriors Trial 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.Check my eligibility
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.See study design
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.
Warriors Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am receiving treatment for high eye pressure at this facility.
Select...
I experience significant pain most days.
Warriors Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Defense and Veterans Pain Rating Scale (DVPRS)
Secondary outcome measures
Change in Clinician Administered PTSD Scale-5 (CAPS5)
Brain-derived neurotrophic factor
Changes in BDNF in saliva
+5 moreWarriors 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
~640
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,639 Previous Clinical Trials
2,560,546 Total Patients Enrolled
Sheila Rauch, PhDPrincipal InvestigatorEmory University
2 Previous Clinical Trials
259 Total Patients Enrolled
Barbara O RothbaumPrincipal InvestigatorEmory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to use the device on myself and follow the study's procedures.I experience significant pain most days.I am receiving treatment for high eye pressure at this facility.I have a history of seizures.I have had a stroke in the past.I have new issues with balance, walking, bladder or bowel control, or I feel numbness, tingling, or weakness.I have had brain surgery in the past.I am unable to give consent for medical procedures.I am under the age of 18.I am between 18 and 89 years old.You are qualified for EHVP-IOP PTSD or Unified Protocol tracks.I have a seizure disorder.You have metal implanted inside your head.You have a pacemaker implanted in your body.I am not currently taking specific heart, seizure, or certain pain and mood medications.I have had a brain tumor.
Research Study Groups:
This trial has the following groups:- Group 1: Transcranial Direct-Current Stimulation (tDCS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to sign up for this clinical research study?
"This trial seeks to curate a cohort of 100 people suffering from depression, aged between 18 and 89. Eligibility requirements include being male or female, living in either Georgia or Florida for long-term follow-up sessions, having an established primary care provider (PCP), self-administering tdcs as well as completing necessary measures; with the most pertinent criterion stipulating that participants must experience pain intensity of 4+ at least 3 days per week."
Answered by AI
Could prospective participants still join this clinical experiment?
"This clinical trial, which was first listed on March 4th 2022, is actively recruiting patients. The study details have been updated as recently as March 14th 2022."
Answered by AI
Are participants of this investigation over 25 years old?
"Individuals of legal age (over 18) who are younger than 89 years old can participate in this medical trial."
Answered by AI
How extensive is the participation in this clinical trial?
"Affirmative. Details found on clinicaltrials.gov demonstrate that this medical trial is presently recruiting patients, with the original post dating back to March 4th 2022 and last updated on March 14th of the same year. 100 people are expected to sign up from 1 site."
Answered by AI
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