TMS for PTSD in Youth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-20
SponsorThe University of Texas Health Science Center at San Antonio
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
MagPro R30 with robotic arm
DeviceTMS 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: TMS treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Side Effects of TMS treatment
number of side effects reported per participant
Time frame
Day 1 of treatment through Day 302
Number of Adverse Events
Number of adverse events experienced by study participants through the treatment phase of the study
Time frame
Day 1 of treatment through Day 303
Completion rate of Treatment
Number of participants that completed the TMS treatment
Time frame
Day 1 of treatment through Day 30Secondary outcomes
1
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.
Time frame
Baseline to 90 days2
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.
Time frame
Baseline to Day 30Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center at San Antonio
Lead sponsor
Texas Child Mental Health Care Consortium: TCMHCC
Collaborator
Source ClinicalTrials.gov