Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation
NCT06544408 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132
Last updated 2026-05-20
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.
Conditions
- Post Traumatic Stress Disorder
- Traumatic Brain Injury
Interventions
- 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.
Sponsors & Collaborators
-
United States Department of Defense
collaborator FED -
Florida State University
lead OTHER
Principal Investigators
-
Frank A Kozel, MD · Florida State University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-06
- Primary Completion
- 2028-06-30
- Completion
- 2028-12-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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