TMS for PTSD in Youth

Purpose

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.

Condition

  • Post Traumatic Stress Disorder (PTSD)

Eligibility

Eligible Ages
Between 12 Years and 20 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Males and females; Age 12-20 2. Have previously completed at least 9 sessions of trauma-focused therapy in our clinical trial or in the community 3. Have current self-reported symptom score of 20 or greater on the UCLA PTSD Reaction index 4. Willing to attend 10 TMS treatment sessions within a 30-day period 5. Fluent in English

Exclusion Criteria

  1. History of seizures 2. History of head injury with loss of consciousness and concussive sequelae 3. Brain abnormality such as tumor or other observable abnormality 4. Currently receiving psychotherapy or TMS treatment 5. Currently pregnant 6. MRI contraindications (metal in body, orthodontic braces) 7. Diagnosis of bipolar 1 or a psychotic disorder

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Open label single group design
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TMS treatment group
Each treatment visit will take about 1.5 hours. Participants will receive up to 4 TMS treatment sessions during the visit, with each session lasting about 10-minutes. After the TMS sessions, there will be a brief visit with a psychotherapist.
  • 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.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Amy S Garrett, PhD
210-567-8189
GarrettAS@uthscsa.edu

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.