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.
This study will have three phases: an acute phase (1 week of treatments), an extension phase (second week of treatments), and a long-term observational follow-up phase of 6 months. The acute phase will be a three-arm randomized sham-controlled trial with: Arm 1 = active left dl-PFC accel-TMS; Arm 2 = active dm-PFC accel-TMS; and Arm 3 = sham accel-TMS (half with sham dl-PFC and half with sham dm-PFC coil positioning). In the subsequent extension phase, all participants will receive active left dl-PFC accel-TMS. For the follow-up phase, clinical outcomes will be assessed at 1-month, 3-months, and 6-months. The primary outcome measure will be the CAPS-5. A range of other secondary outcome measures will also be included.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
132
One 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).
One 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).
One 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.
Florida State University
Tallahassee, Florida, United States
RECRUITINGClinician-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.
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.
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.
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.
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One 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.
The 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.
Time frame: Assessment of symptoms during the preceding week before each follow-up visit.
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.
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.