N/A
Completed N=119
Image-guided, Robotically Delivered Transcranial Magnetic Stimulation Treatment for Combat-Related Post-Traumatic Stress Disorder
Stress Disorders, Post-Traumatic
Source: ClinicalTrials.gov NCT02853032 ↗
Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Change in PTSD Severity as Measured by the PTSD Checklist (PCL-5) — 59.82; 60.45; 33.29; 39.14 score on a scale
Summary
Mounting amounts of evidence suggests that non-invasive stimulation of the dorsolateral prefrontal cortex (DLPFC) using repetitive transcranial magnetic stimulation (rTMS) maybe a safe and effective treatment modality for Post-Traumatic Stress Disorder (PTSD). However the large variability in the magnitude of clinical outcomes reported is likely related to the current lack of knowledge of ideal side of stimulation (left vs right) and the limited precision in the targeting of brain circuits needed to obtain an optimal treatment response. In this protocol the investigators will: 1) generate individualized treatment plans based on an individual's functional Magnetic Resonance Imaging (fMRI) and meta-analytical based connectivity analysis to guide the delivery of adjunct, imaging-based & robotically delivered rTMS to active duty military (ADM) subjects with PTSD participating in an intensive program providing integrated evidence-based psychotherapy and pharmacological management (Treatment as Usual (TAU)). 2) To use clinician ratings and self-report PTSD symptom scales, as well as other indicators of clinical change, to determine whether compared with TAU, addition of adjunct rTMS improves clinical outcomes. 3) To conduct neuroimaging-based assessments aimed to measure rTMS effects on network connectivity in ADM receiving treatment for PTSD and the potential correlation of connectivity changes with clinical outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PTSD Severity as Measured by the PTSD Checklist (PCL-5) |
59.82; 60.45; 33.29; 39.14 | — |
| SECONDARY Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) |
17.80; 19.31; 13.87; 16.86 | — |
| SECONDARY Change in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS) |
25.55; 28.12; 20.50; 21.75 | — |
| SECONDARY Change in PTSD Severity as Measured by the PTSD Checklist for DSM-5 (PCL-5) |
59.82; 60.45; 34.47; 46.64 | — |
| SECONDARY Change in PTSD Severity as Measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) |
45.05; 46.12; 24.83; 31.00 | — |
| SECONDARY Change in PTSD Severity as Measured by the Clinician-Administered PTSD Scale (CAPS-5) |
45.05; 46.12; 28.58; 31.45 | — |
| SECONDARY Clinically Significant Response as Measured by the PTSD Checklist for DSM-5 (PCL-5) |
-40.20; -17.01 | — |
| SECONDARY Clinically Significant Response in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) |
-28.35; 19.36 | — |
| SECONDARY Clinically Significant Response in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS) |
-22.65; -20.47 | — |
| SECONDARY Clinically Significant Response as Measured by the Clinician-Administered PTSD Scale (CAPS-5) |
-31.32; -27.64 | — |
| SECONDARY Remission From PTSD as Measured by the PTSD Checklist for DSM-5 (PCL-5) |
60.00; 21.43 | — |
| SECONDARY Remission From Depression as Measured by the 9-item Patient Health Questionnaire (PHQ-9) |
60.00; 35.71 | — |
| SECONDARY Remission From Depression as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS) |
25.00; 25.00 | — |
| SECONDARY Remission From PTSD as Measured by the Clinician-Administered PTSD Scale (CAPS-5) |
41.67; 27.27 | — |
| SECONDARY Functional Connectivity Changes (Measured by Resting-state Functional Magnetic Resonance Imaging) of the Targeted Brain Network(s) Following rTMS Treatment |
-1.02; 1.17 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events |
36; 32; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female English-speaking active duty or recently retired veteran patients who have deployed post 9/11 receiving treatment at LRTC between the ages of 18-65 years;
- Patients must have a diagnosis of PTSD confirmed by the Clinician-Administered PTSD Scale (CAPS-5) at screening,
- Subjects must have a minimum PTSD Symptom Checklist (PCL-5) for DSM-V symptom severity rating of 25.
Exclusion Criteria
- Subjects with a diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder as documented in the medical record.
- Substance use disorder during the 12 months prior to screening; except that Mild - Moderate, but not Severe, Alcohol Use Disorder (using DSM-5 criteria) will be allowed as determined by LRTC medical provider review.
- Any history or signs of serious medical or neurological illness including seizure disorders. Except for seizures, a subject with a clinical abnormality may be included only if the study clinician considers the illness will not introduce additional risk and will not interfere with the study procedures. This will be determined during the screening phase via self-report and/or medical history review.
- History of traumatic brain injury (TBI) with loss of consciousness for 20 minutes or more as determined by the History of Head Injuries questionnaire.
- Females will be excluded if they are pregnant (i.e. positive pregnancy test identified after their LRTC intake).
- 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 as indicated by self-report. MRI can have risks for persons with foreign bodies implanted in their body.
Data sourced from ClinicalTrials.gov (NCT02853032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.