TMS for PTSD in Youth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MagPro R30 with robotic arm.
- Who it may be relevant to
- Registry conditions: Post Traumatic Stress Disorder (PTSD). Basic parameters: 12 years — 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transcranial Magnetic Stimulation as Treatment for Persistent PTSD in Texas Youth
Overview
The purpose of this study is to test whether transcranial magnetic stimulation, or TMS, is an acceptable and helpful treatment for ongoing symptoms of posttraumatic stress syndrome disorder (PTSD) in 12-20 year olds. Ongoing PTSD refers to symptoms that continue after completing trauma-focused psychotherapy. About 1 in 4 patients need additional help to overcome PTSD after completing psychotherapy. Currently, scientists do not know the best way to help adolescents with persistent PTSD, and this study will test TMS as a possible treatment, and hopefully lead to future studies including more people.
Detailed description
Trauma is a common occurrence among youth. Almost 60% of American youths experience a traumatic event before age 18, such as physical or sexual abuse, sudden loss of caregivers, or witnessing violence in the community or the home. Distress after a significantly traumatic event is to be expected, but for some youths, symptoms of posttraumatic stress disorder (PTSD) linger for months or years, and can become chronic if left untreated. Symptoms of PTSD can include upsetting memories, avoidance of reminders, and emotional numbing, and other symptoms. These symptoms can create difficulties for family relationships, friendships, and schoolwork. Currently, the most effective treatment for PTSD is talk therapy (trauma-focused psychotherapy). However, sometimes young people continue to have symptoms of PTSD after completing talk therapy, and it is currently not known the best way to help with these persistent symptoms.
In this study, the total length of time participants will be involved in the study is about 16-weeks. During that time, participants will be asked to attend approximately 6 research visits and 10 treatment visits, for a total of 16 visits. The 6 research visits include a screening visit, an interview visit, 2 MRI visits, and 2 follow-up visits. The screening, interview, and follow-up visits can be completed virtually, over zoom. The study will include 2 MRI visits and 10 treatment visits. Virtual follow-up visits will be conducted 1 and 3 months after completion of treatment and will include interviews and questionnaires about participants symptoms.
Interventions
- Device MagPro R30 with robotic arm
TMS will be delivered to the right anterior dorsolateral frontal cortex. The accelerated protocol consists of 1,800 TMS pulses per session, delivered at intensity ranges designed to deliver depth-corrected E-fields of 80-95 volts/meter. The exact intensity will be determined when the participant's treatment plan is developed. Once a patient's TMS treatment plan has been created, it will be used for every treatment session for that participant.
Primary outcome measures
- Side Effects of TMS treatment [Time frame: Day 1 of treatment through Day 30]
- Number of Adverse Events [Time frame: Day 1 of treatment through Day 30]
- Completion rate of Treatment [Time frame: Day 1 of treatment through Day 30]
Secondary outcome measures (2)
- Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)(CAPS-5) [Time frame: Baseline to 90 days]
- Assessment of Depression using Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline to Day 30]
Eligibility criteria
Inclusion criteria
- Males and females; Age 12-20
- Have previously completed at least 9 sessions of trauma-focused therapy in our clinical trial or in the community
- Have current self-reported symptom score of 20 or greater on the UCLA PTSD Reaction index
- Willing to attend 10 TMS treatment sessions within a 30-day period
- Fluent in English
Exclusion criteria
- History of seizures
- History of head injury with loss of consciousness and concussive sequelae
- Brain abnormality such as tumor or other observable abnormality
- Currently receiving psychotherapy or TMS treatment
- Currently pregnant
- MRI contraindications (metal in body, orthodontic braces)
- Diagnosis of bipolar 1 or a psychotic disorder
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UT Health Department of Psychiatry — San Antonio
Identifiers
NCT: NCT07401225 · STUDY00002052 · NECMHR02