NCT06544408

Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Florida State University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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, and 6-months. The primary outcome measure will be the CAPS-5. A range of other secondary outcome measures will also be included.

Conditions

• Post Traumatic Stress Disorder
• Traumatic Brain Injury

Interventions

Type	Name	Description
DEVICE	Cool 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).
DEVICE	Cool 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).
DEVICE	Cool 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.
DEVICE	Cool 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.
DEVICE	Cool 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.

Timeline

• Start date: 2024-11-06
• Primary completion: 2028-06-30
• Completion: 2028-12-30
• First posted: 2024-08-09
• Last updated: 2025-05-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study