Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFlorida State University
About this trial
This study will test the clinical efficacy of an accelerated TMS (accel-TMS) protocol that rapidly addresses PTSD symptoms with 1 week (25 sessions over 5 days) of condensed treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults age 18 years to 65 years old.
Meets DSM-5 criteria for PTSD with a PCL-5 score > 33
No changes in psychotropic medication (if taking psychotropic medication) and/or changes in supportive psychotherapy for 1 month prior to initial visit; and clinically appropriate to maintain stable treatment regimen for duration of trial.
Clinically competent to give informed written consent and ability to understand study procedures and to comply with them for the entire length of the study
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Cool B70 AP Coil - Active (dl-PFC)
DeviceOne side of the coil is the active and the other is sham. The B70 AP coil will be positioned over the left dorsolateral prefrontal cortex (dl-PFC).
Cool B70 AP Coil- Sham (dl-PFC)
DeviceOne side of the coil is the active and the other is sham. The B70 AP coil will be positioned over the left dorsolateral prefrontal cortex (dl-PFC).
Cool D-B80 AP Coil - Active (dm-PFC)
DeviceOne side of the coil is the active and the other is sham. The cool D-B80 AP coil will be positioned over the midline (bilateral) dorsal medial prefrontal cortex (dmPFC) using location 25.8% distance from nasion to inion.
Cool D-B80 AP Coil - Sham (dm-PFC)
DeviceOne side of the coil is the active and the other is sham. The cool D-B80 AP coil will be positioned over the midline (bilateral) dorsal medial prefrontal cortex (dmPFC) using location 25.8% distance from nasion to inion.
Cool B70 Treatment Coil - Active Only
DeviceThe treatment will be the same as the left dl-PFC accel-TMS dl-PFC except that the Cool B70 Treatment coil only has an active treatment coil.
Treatment groups
132 Participants
are divided into 5 treatment groupsGroup A: Arm 1: active left dl-PFC accel-TMSActive comparator 1 intervention
Group B: Arm 2:active dm-PFC accel-TMSActive comparator 1 intervention
Group C: Arm 3 - sham accel-TMS dl-PFCSham comparator 1 intervention
Group D: Arm 4: sham accel -TMS dm-PFCSham comparator 1 intervention
Group E: Arm 5Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine left dl-PFC accel-TMS efficacy
CAPS-V is a 30-item clinical interview used to diagnose PTSD as well as monitor PTSD symptoms. Questions address the traumatic event(s), symptom duration, subjective distress, impact on functioning, dissociation, and symptom improvement since last evaluation. During the Acute Phase, CAPS-V will be used to determine the rapid efficacy of left dl-PFC accel-TMS compared to sham accel-TMS at approximately one-week post-treatment.
Time frame
Assessment of symptoms during the preceding week.2
Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine dm-PFC accel-TMS efficacy
A 30-item clinical interview used to diagnose PTSD as well as monitor PTSD symptoms. Questions address the traumatic event(s), symptom duration, subjective distress, impact on functioning, dissociation, and symptom improvement since last evaluation. During the Acute Phase, CAPS-V will be used to determine the rapid efficacy of dm-PFC accel-TMS compared to sham accel-TMS at approximately one-week post-treatment
Time frame
Assessment of symptoms during the preceding week.3
Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine superior symptom reduction
A 30-item clinical interview used to diagnose PTSD as well as monitor PTSD symptoms. Questions address the traumatic event(s), symptom duration, subjective distress, impact on functioning, dissociation, and symptom improvement since last evaluation. During the Extension Phase, CAPS-V will be used to determine whether an additional week of left dl-PFC accel-TMS provides superior reduction of PTSD symptoms compared to one week of left dl-PFC accel-TMS.
Time frame
Assessment of symptoms during the preceding week.Secondary outcomes
1
Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to characterize durability of accel-TMS effects
A 30-item clinical interview used to diagnose PTSD as well as monitor PTSD symptoms. Questions address the traumatic event(s), symptom duration, subjective distress, impact on functioning, dissociation, and symptom improvement since last evaluation. During Follow-Up Phase to characterize the durability of accel-TMS effects on PTSD symptoms at 1-month, 3-months, and 6-months post treatment.
Time frame
Assessment of symptoms during the preceding week before each follow-up visit.2
Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine superior outcomes between active left dl-PFC and active dm-PFC accel-TMS
A 30-item clinical interview used to diagnose PTSD as well as monitor PTSD symptoms. Questions address the traumatic event(s), symptom duration, subjective distress, impact on functioning, dissociation, and symptom improvement since last evaluation. During the Acute Phase to determine whether active left dl-PFC or active dm-PFC accel-TMS produces superior outcomes for PTSD symptoms
Time frame
Assessment of symptoms during the preceding week.3
Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine added benefit during Extension
A 30-item clinical interview used to diagnose PTSD as well as monitor PTSD symptoms. Questions address the traumatic event(s), symptom duration, subjective distress, impact on functioning, dissociation, and symptom improvement since last evaluation. During the Extension Phase to determine whether an additional week of open left dl-PFC accel-TMS will provide added benefit to those participants that received active dm-PFC accel-TMS (i.e., targeting 2 brain regions versus 1 brain region).
Time frame
Assessment of symptoms during the preceding week.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Florida State University
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov