Clinical trial NCT06587659: Accelerated Image-Guided Robotically Delivered Transcranial Magnetic Stimulation for Combat PTSD
Official title: Accelerated Image-Guided Robotically Delivered Transcranial Magnetic Stimulation for Combat PTSD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Nonrandomized, open-label trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in PTSD Severity as Measured by the PTSD Checklist (PCL-5)
timeFrame: Baseline to two weeks (the conclusion of IR-TMS treatment)
Secondary outcomes:
measure: Change in PTSD Severity as Measured by the PTSD Checklist (PCL-5)
timeFrame: Baseline to one week (mid IR-TMS treatment)
measure: Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline to one week (mid IR-TMS treatment)
measure: Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline to two weeks (the conclusion of IR-TMS treatment)
measure: Change in PTSD Severity as Measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Baseline to six weeks (4 weeks post IR-TMS treatment)
measure: Change in PTSD Severity as Measured by the PTSD Checklist (PCL-5)
timeFrame: Baseline to six weeks (4 weeks post IR-TMS treatment)
measure: Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline to six weeks (4 weeks post IR-TMS treatment)
measure: Change in PTSD Severity as Measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Baseline to fourteen weeks (12 weeks post IR-TMS treatment)
measure: Change in PTSD Severity as Measured by the PTSD Checklist (PCL-5)
timeFrame: Baseline to fourteen weeks (12 weeks post IR-TMS treatment)
measure: Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline to fourteen weeks (12 weeks post IR-TMS treatment)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Research Imaging Institute
state: Texas
Study officials:
affiliation: University of Texas Health at San Antonio
name: Felipe S Salinas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: