TMS for PTSD in Youth

Transcranial Magnetic Stimulation as Treatment for Persistent PTSD in Texas Youth

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.

Study Overview

• Status: Recruiting
• Conditions: Post Traumatic Stress Disorder (PTSD)
• Intervention / Treatment: Device: MagPro R30 with robotic arm

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy S Garrett, PhD; Phone Number: 210-567-8189; Email: GarrettAS@uthscsa.edu

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • UT Health Department of Psychiatry
      • Contact: Amy Garrett, PhD; Phone Number: 2105678189; Email: garrettas@uthscsa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side Effects of TMS treatment	number of side effects reported per participant	Day 1 of treatment through Day 30
Number of Adverse Events	Number of adverse events experienced by study participants through the treatment phase of the study	Day 1 of treatment through Day 30
Completion rate of Treatment	Number of participants that completed the TMS treatment	Day 1 of treatment through Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)(CAPS-5)	The CAPS-5 score range for total symptom severity is 0 to 80, calculated by summing the severity ratings (0-4) for 20 PTSD symptoms, with higher scores indicating greater severity; scores below 31-33 often suggest subclinical or non-diagnostic levels, while scores above this range can indicate probable PTSD.	Baseline to 90 days
Assessment of Depression using Patient Health Questionnaire-9 (PHQ-9)	Patients rate 9 common depressive symptoms (e.g., feeling down, trouble sleeping, low energy, poor appetite, concentration issues, feeling bad about self, restlessness/slowed down, thoughts of being better off dead/hurting self). Scoring: Each symptom gets 0-3 points, totaling 0-27. A lower score indicates less depression.	Baseline to Day 30

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: Texas Child Mental Health Care Consortium: TCMHCC
• Investigators: Principal Investigator: Amy S Garrett, PhD, The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Estimated): May 9, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Transcranial Magnetic Stimulation; Transcranial Magnetic Stimulation (TMS)
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: STUDY00002052; NECMHR02 (Other Identifier: Texas Childhood Mental Healthcare Consortium (TCMHCC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: requests for data will be considered on a case-by-case basis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No