Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation

NCT06544408 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-05-20

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06544408 on ClinicalTrials.gov