PTSD Study
If you are experiencing symptoms of Post-Traumatic Stress Disorder (PTSD) lasting 6 months or longer, you may be eligible to participate.
Symptoms may include: thoughts, memories or feelings that impair daily function, sleep disturbance, dizziness, forgetfulness, fatigue, feeling depressed or sad.
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Screening period
If you consent to participate, we will collect information about your medical status and history to determine if you are a good candidate to receive the investigational treatment. This process requires virtual and in-person appointments over a 1-3 weeks period.
Investigational treatment
You will be randomly assigned to the sham or active study treatment.
25 in-clinic daily visits over a 5-to-6 week period
Each visit will consist of a 45-minute session. These appointments will take place at the research site, with daily attendance Monday-Friday.
Data Collection
Data collection sessions will occur remotely. Data collection will occur during the initial screening visits, during study treatment visits, at the end of study treatment and 3 months & 6 months after study treatment begins.
Additional active study treatments (optional)
For the first 5-6 weeks of study treatment visits you will receive active or sham (placebo) study treatment. You have a 50/50 chance of being assigned to the sham or active group. However, everyone who completes 80% of their assigned study treatments and participates fully in data collection is guaranteed to receive active treatment as long as it remains safe to treat them. This is because there is an open-label period of optional active study treatment offered to those who were assigned to sham. The open-label period is 25 active study treatments beginning shortly after the 25 sham treatments are over.
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Participants may be compensated up to $2,550. More information on compensation is given during the informed consent process. No screening will occur before you give your informed consent.
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This study is investigating the safety and efficacy of Magnetic eResonance Therapy or (MeRT) for Post-traumatic Stress Disorder (PTSD). MeRT is a personalized, non-invasive and non-pharmacological investigative treatment using electromagnetic stimulation of the brain. MeRT uses transcranial magnetic stimulation (TMS), which has been cleared by the FDA for treatment-resistant Major Depressive Disorder, Obsessive Compulsive Disorder, and Nicotine Cessation. The device generates magnetic waves that allow us to stimulate specifically targeted areas of the brain. It is a non-invasive and drug-free option being researched for a number of neurological conditions.
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Study sites are in Plano Texas, Bryn Mawr Pennsylvania and Columbus Ohio. Additional sites may be added.
Keep scrolling for more details about our study.
What is MeRT?
Magnetic eResonance Therapy or (MeRT) is a personalized, non-invasive and non-pharmacological investigative treatment using electromagnetic stimulation of the brain. MeRT uses transcranial magnetic stimulation (TMS), which has been cleared by the FDA for treatment-resistant Major Depressive Disorder, Obsessive Compulsive Disorder, and Nicotine Cessation. The device generates magnetic waves that allow us to stimulate specifically targeted areas of the brain. It is a non-invasive and drug-free option.
It all starts with an EEG.
An EEG is a painless, 10-minute brainwave recording that measures the electrical activity in your brain using small electrodes attached to a helmet device. It cannot read your mind or your thoughts, simply the electrical activity of your neurons.
The investigative algorithm uses this signal to compute personalized treatment parameters for the study treatment.
Study treatment sessions
Study treatment sessions consist of sitting comfortably while a magnetic coil is gently placed on your forehead. A typical MeRT appointment lasts approximately 45-minutes.
In search for the solution…
Transforming health through discovery and education
From cancer and heart failure to bacterial infections and neurological defects, researchers at the Texas A&M Institute of Biosciences and Technology in Houston work to improve the quality of health care through innovative research and education. Our mission is to perform innovative translational biomedical research and to transfer discoveries to the classroom, clinic and marketplace.
The Braincare specialists
Wave Neuroscience provides technology to deliver EEG guided personalized neuromodulation. Their technology is utilized in over 60 clinics worldwide.
Trial status:
Phase I: COMPLETE
Phase II: NOW ENROLLING PARTICIPANTS
FDA Clearance: PENDING RESULTS OF STUDY
Am I eligible?
Signs this study may be right for you.
Some key indicators that you may qualify for this study.
✓ 18-65 years old
✓ Experiencing symptoms of PTSD
✓ No significant medical disorders
✓ Not taking certain prescription drugs or using neurostimulation devices
✓ No iron-containing metal implants near the head or medical devices that could be affected by a magnetic field
Sponsoring Institutions
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Dr. Kenneth Ramos, MD, PHD, Executive Director of Texas A&M Health Institute of Biosciences and Technology, and Principal Investigator of this Study.
PRINCIPAL INVESTIGATOR
“The initial phase of this trial was carried out in a military population with persistent post-concussive symptoms following TBI, some of whom suffered from PTSD symptoms. This second phase of the investigation has been designed to evaluate the efficacy and safety of MeRT in a civilian PTSD cohort in a larger and more diverse group of participants. Our goal is to find ways to improve the quality of life for patients afflicted with this devastating condition.”
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Dr. Erik Won, DO, Chief Medical Officer of Wave Neuroscience, and representative to this study
“This trial will build on the amazing work of our Phase I collaboration with U.S. Special Operations Command, Uniformed Services University of the Health Sciences, and the Henry M Jackson Foundation while facilitating the incorporation of civilians and non-military participants into our study population. Our goal is to provide the most academically rigorous and scientifically robust methodology to provide confirmatory data in support of our mission to help vulnerable populations struggling with PTSD, including PTSD with persistent post-concussive symptoms following TBI.”
3 easy steps to
getting started…
1. Fill out Entry Questionnaire
Contact our trial coordinators via phone call or fill out our contact form on this website.
2. Clear Screening Process
Provide your informed consent after having the study requirements, risks and benefits, thoroughly explained to you, and all your questions answered. Supply our coordinators with all requested information in order to move through the screening process and to ensure you’re a good fit for our study.
3. Begin your Study Treatment Sessions
Sit back and relax during your daily visits to your local trial site. The Study Treatment that is administered may be active or sham. But, if you are assigned to sham, you may opt-in for the open-label active study treatments.
3 Convenient Study Locations
Texas A&M Research Center, Texas
4716 Alliance Blvd.
Pavillion 2, Suite 260
Plano, TX 75093
Study Coordinator
214-774-2290
dallas.coordinator@mertptsdtrial.com
Center for Interventional Pain and Spine
931 E Haverford Rd. Suite 202
Bryn Mawr, PA, 19010
Study Coordinator
717-799-3270
pa.coordinator@mertptsdtrial.com
Columbus Brain Research Center
4449 Easton Way Suite 2015
Columbus, Ohio 43219
Study Coordinator
330-340-5988
oh.coordinator@mertptsdtrial.com
FAQs
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Yes! Individuals may be compensated. More information on compensation is given during the informed consent process.
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Participants need to complete their assigned treatments and participate in the data collection in order for us to gather sufficient data from our study. If you cannot commit to completing these procedures this study is not a good fit for you and you should not enroll.
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Not at all! This is not Electroconvulsive therapy and does not shock the brain with electricity. Instead, it uses magnets to gently nudge the brainwave pattern.
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From our current data using the MeRT approach, side effects are few and generally mild. The most commonly reported side effect is a mild tension headache at the site of stimulation, which can last 1-2 hours and responds well to over-the-counter analgesics.
Other possible side effects are hyperactivity, increased agitation, or euphoria.
The most recent safety literature on TMS indicates that there is a very rare potential for seizure in individuals who may be at risk or who ingest substances that lower the seizure threshold. Everyone must be screened for safety before they may participate. It is vital that you truthfully answer all safety-related questions.
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Unlike standard rTMS therapy, which delivers stimulation at a fixed frequency for all patients, the MeRT approach individualizes the treatment frequency based on each patient's Quantitative EEG and EKG.
MeRT stimulation is targeted to be delivered at 2/3rds or less of the energy level of standard rTMS therapy.
MeRT is a customized approach to rTMS.
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There is plenty of street parking near the location in San Diego. There is also plenty of parking near our Dallas building.
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The study consists of 25, 45-minute sessions over a 5-6 week period. A few weeks of screening occurs before the study treatment sessions. If you opt-in for the open-label treatments, another 5-6 week period of active study treatment sessions are involved. Finally, two short remote data collection visits will occur at 3 and 6 months after the first study treatment is administered.
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We expect the study to conclude at the end of 2024, with results made public in 2025.