Stress Disorders, Post-Traumatic
Conditions
Brief summary
Posttraumatic stress disorder (PTSD) among military service members and veterans is as high as 32% and is the third most service-connected disability, resulting in over $1.5 billion in direct costs over a five-year period. According to Clinical Practice Guidelines, strong evidence exists for psychotherapies, such as prolonged exposure (PE) for PTSD. However, psychotherapies are often met with high drop-out rates, treatment non-compliance, and emotional stress due to trauma recall. A successful approach to reduce drop-out rates and maintain efficacy is to compress psychotherapy into daily, day-long PE sessions. Yet another deficit exists regarding the feasibility of this approach outside of residential treatment facilities, which are typically reserved for the most extreme cases. The newest study from the our team aimed to augment PE residential treatment with a neuromodulatory treatment: image-guided, robot-navigated transcranial magnetic stimulation (IR-TMS). Along with the PE-focused intensive inpatient program (IIP-PE), participants received IR-TMS targeting the right dorsolateral prefrontal cortex (DLPFC) daily for 20 consecutive days. Results demonstrated superiority of the combined IIP-PE/IR-TMS approach, compared to IIP-PE and a sham condition. However, it is not yet established whether a standalone IR-TMS approach will achieve similar results. Our goal is to implement an open-label trial of IR-TMS for PTSD, in which veterans and active-duty service members with PTSD will receive accelerated IR-TMS throughout a 2-week timeframe. Results will be used as a foundation for future extramural funding to scale-up the stand alone IR-TMS intervention for PTSD treatments.
Detailed description
We propose an open-label, 2-week trial of IR-TMS targeting the right, anterior dorsolateral prefrontal cortex (R-antDLPFC) in 30 PTSD participants. We will recruit Active-Duty Service Members and Veterans with combat PTSD, as determined by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5). Participants will be encouraged to complete as many IR-TMS sessions throughout a 2-week time period, with a maximum of 4 sessions per day. Treatments will be neuro-navigated and adapted for an accelerated TMS treatment schedule. Post-Treatment and durability of this treatment effect will be examined throughout the 1-month and 3-month FU assessments. Findings from this open-label trial of IR-TMS for PTSD will serve as preliminary data for a larger randomized clinical trial to further identify the stand-alone effects of IR-TMS versus a sham condition.
Interventions
DEVICETranscranial Magnetic Stimulation
The MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use. The non-invasive brain stimulation system will be used to deliver active repetitive electromagnetic pulses in this research study's treatment of post-traumatic stress disorder.
DEVICERobotic Arm
This robotic system is based on a commercially available collaborative robot. The robot is mounted on a cart which holds the robot controller and the TMS power supply and pulse-generation computer. The robotic system will be used for TMS coil positioning/targeting.
Sponsors
Trauma Research and Combat Casualty Care Collaborative
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Nonrandomized, open-label trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. between the ages of 18 and 70 years 2. meet diagnostic criteria for PTSD on the CAPS-5 3. able to attend all clinic appointments 4. fluent in English
Exclusion criteria
1. a documented diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder or a psychiatric hospitalization in the last 12 months 2. significant cognitive impairment determined by inability to comprehend screening assessment 3. psychiatric problems and/or high suicide risk warranting immediate intervention, as assessed with the PHQ-9 (Item #9) 4. currently meeting a psychiatric diagnosis of alcohol and/or substance abuse that would prevent the participant from engaging in therapy 5. any history or signs of serious medical or neurological illness including seizure disorders 6. history of traumatic brain injury (TBI) with loss of consciousness for 20 minutes or more 7. females will be excluded if they are pregnant 8. any history or signs of metal objects deemed unsafe for MRI or that may adversely affect image quality of the brain region (e.g. surgical clips, cardiac pacemakers, metal implants, etc.) in the body at the time of screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PTSD Severity as Measured by the PTSD Checklist (PCL-5) | Baseline to two weeks (the conclusion of IR-TMS treatment) | PTSD Checklist for DSM-5 (PCL-5) has excellent psychometric characteristics for screening and as a secondary indicator of PTSD symptom severity. The PCL-5 is a 20-item self-report measure, selected for its dimensional sensitivity, with higher scores reflecting greater PTSD severity. Scoring is based on how much the participant has been bothered by the symptoms in the past month on a scale from 0 = not at all to 4 = extremely. Items are summed to provide a total severity score (range = 0-80). If the participant scores above 33 in total, it is probable that they have PTSD. A clinically significant change in the PCL-5 is a 10-20 point change in the total symptom severity score. A 5-10 point change is considered a reliable change, meaning it is not due to chance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PTSD Severity as Measured by the PTSD Checklist (PCL-5) | Baseline to one week (mid IR-TMS treatment) | PTSD Checklist for DSM-5 (PCL-5) has excellent psychometric characteristics for screening and as a secondary indicator of PTSD symptom severity. The PCL-5 is a 20-item self-report measure, selected for its dimensional sensitivity, with higher scores reflecting greater PTSD severity. Scoring is based on how much the participant has been bothered by the symptoms in the past month on a scale from 0 = not at all to 4 = extremely. Items are summed to provide a total severity score (range = 0-80). If the participant scores above 33 in total, it is probable that they have PTSD. A clinically significant change in the PCL-5 is a 10-20 point change in the total symptom severity score. A 5-10 point change is considered a reliable change, meaning it is not due to chance. |
| Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) | Baseline to one week (mid IR-TMS treatment) | The Participant Health Questionnaire-9 (PHQ-9) is a widely used and well-validated instrument for measuring the severity of depressive symptoms. It consists of 9 items that assess both affective and somatic symptoms related to depression and depressive disorders; these 9 items correspond to the DSM diagnostic criteria for Major Depressive Disorder. Respondents rate the frequency with which they have been bothered by depressive symptoms within the past two weeks on a scale ranging from 0 (not at all) to 3 (nearly every day); PHQ-9 scores range from 0 to 27. Scores reflect no significant depressive symptoms (0-4), mild depressive symptoms (5-9), moderate depressive symptoms (10-14), moderately severe depressive symptoms (15-19), and severe depressive symptoms (20-27). A 5-point change is clinically significant. A score of less than 10 suggests a partial response, and a score of less than 5 represents remission. |
| Change in PTSD Severity as Measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | Baseline to six weeks (4 weeks post IR-TMS treatment) | The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a structured diagnostic interview and gold standard for assessing PTSD. The scale also assesses social and occupational functioning, dissociation, and the validity of symptom reports. Symptom severity ratings combine information about symptom frequency and intensity obtained by the interviewer. CAPS-5 scores range from 0 to 80 with higher scores indicating greater PTSD symptom severity. A clinically significant change in the CAPS-5 is a score of 8 or less. A reliable change in CAPS-5 scores is a change of 13 or more. |
Countries
United States
Outcome results
None listed