Post Traumatic Stress Disorder (PTSD)
Conditions
Keywords
Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation (TMS)
Brief summary
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
DEVICEMagPro 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.
Sponsors
The University of Texas Health Science Center at San Antonio
Texas Child Mental Health Care Consortium: TCMHCC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label single group design
Eligibility
Sex/Gender
ALL
Age
12 Years to 20 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Side Effects of TMS treatment | Day 1 of treatment through Day 30 | number of side effects reported per participant |
| Number of Adverse Events | Day 1 of treatment through Day 30 | Number of adverse events experienced by study participants through the treatment phase of the study |
| Completion rate of Treatment | Day 1 of treatment through Day 30 | Number of participants that completed the TMS treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)(CAPS-5) | 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. |
| Assessment of Depression using Patient Health Questionnaire-9 (PHQ-9) | 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. |
Countries
United States
Contacts
CONTACTAmy S Garrett, PhD
PRINCIPAL_INVESTIGATORAmy S Garrett, PhD
The University of Texas Health Science Center at San Antonio
Outcome results
None listed