UT Health Department of Psychiatry
San Antonio, Texas, 78229, United States
Location status: Recruiting
NCT Number: NCT07401225
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.
Interested in participating?
Request Info12 year–20 year
All sexes
Interventional
Not applicable
San Antonio, Texas, 78229, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 1 of treatment through Day 30
number of side effects reported per participant
Time frame: Day 1 of treatment through Day 30
Number of adverse events experienced by study participants through the treatment phase of the study
Time frame: Day 1 of treatment through Day 30
Number of participants that completed the TMS treatment
Time frame: Baseline to 90 days
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.
Time frame: Baseline to Day 30
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.
Contact information is provided by the study sponsor or research team.
The University of Texas Health Science Center at San Antonio
Other
Transcranial Magnetic Stimulation as Treatment for Persistent PTSD in Texas Youth
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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