Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation
Florida State University
Summary
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.
Description
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,…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion: 1. Adults age 18 years to 65 years old. 2. Meets DSM-5 criteria for PTSD with a PCL-5 score \> 33 3. 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. 4. 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 Exclusion: 1. Medical contraindication for neuromodulation (e.g., ferrous metal in hea…
Interventions
- DeviceCool B70 AP Coil - Active (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).
- DeviceCool B70 AP Coil- Sham (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).
- DeviceCool D-B80 AP Coil - Active (dm-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.
- DeviceCool D-B80 AP Coil - Sham (dm-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.
- DeviceCool B70 Treatment Coil - Active Only
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.
Location
- Florida State UniversityTallahassee, Florida