Recruiting

Non-Invasive Brain Stimulation

Sponsor:

Florida State University

Code:

NCT06544408

Conditions

Post Traumatic Stress Disorder

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cool B70 AP Coil - Active (dl-PFC)

Cool B70 AP Coil- Sham (dl-PFC)

Cool D-B80 AP Coil - Active (dm-PFC)

Cool D-B80 AP Coil - Sham (dm-PFC)

Cool B70 Treatment Coil - Active Only

Study Details

Brief 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

Study ID

NCT06544408

Start date

Nov 6, 2024

Status verified date

May, 2026

Completion date

Dec 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).
2. Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment.
3. Dementia or other cognitive disorder making unable to engage in treatment.
4. Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness that precludes safe participation in trial.
5. Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide.
6. OCD cannot be the primary disorder but can have OCD symptoms.
7. Inability to stop taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)
8. Current, planned, or suspected pregnancy
9. Unstable medical conditions or any current medical condition that could preclude being able to safely participate in TMS treatment (e.g., unstable metabolic abnormality, unstable angina, etc.)
10. Severe Traumatic Brain Injury
11. We will exclude non-English speakers because of the need for rapid communication during the delivery of treatments.
12. Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation).
13. Prior known active TMS of dorsolateral prefrontal cortex or dorsomedial prefrontal cortex or electroconvulsive therapy (ECT) -

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Arm 1: active left dl-PFC accel-TMS

Acute Phase: Eligible participants will be randomized into one of the three treatment groups: active left dl-PFC accel-TMS vs. active dm-PFC accel-TMS vs. sham dl-PFC/dm-PFC accel TMS

active comparator: Arm 2:active dm-PFC accel-TMS

Acute Phase: Eligible participants will be randomized into one of the three treatment groups: active left dl-PFC accel-TMS vs. active dm-PFC accel-TMS vs. sham dl-PFC/dm-PFC accel TMS

sham comparator: Arm 3 - sham accel-TMS dl-PFC

Acute Phase: Eligible participants will be randomized into one of the three treatment groups: active left dl-PFC accel-TMS vs. active dm-PFC accel-TMS vs. sham dl-PFC/dm-PFC accel TMS

sham comparator: Arm 4: sham accel -TMS dm-PFC

Acute Phase: Eligible participants will be randomized into one of the three treatment groups: active left dl-PFC accel-TMS vs. active dm-PFC accel-TMS vs. sham dl-PFC/dm-PFC accel TMS

active comparator: Arm 5

Extension phase, all participants will receive active left dl-PFC accel-TMS.

Interventions

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).

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).

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.

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.

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.

Primary outcome measure

  • Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine left dl-PFC accel-TMS efficacy [ 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 [ Time Frame: Assessment of symptoms during the preceding week. ]
  • Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine superior symptom reduction [ Time Frame: Assessment of symptoms during the preceding week. ]

Central Contacts and Locations

Central contacts

Isabelle M Taylor, MA

850-644-2824fsun@fsu.edu

Kevin A Johnson, PhD

850-644-2824fsun@fsu.edu

Locations

Florida State University

Recruiting

Tallahassee, Florida, United States, 32306

Contacts

Isabelle M Taylor, MA

850-644-2824fsun@fsu.edu

Kevin A Johnson, PhD

850-644-2824fsun@fsu.edu

Principal Investigator:

Frank A Kozel, MD

More Information

Sponsor

Florida State University

Last update posted

May 20, 2026

Last verified

May, 2026

Keywords

  • PTSD
  • TMS
  • Transcranial Magnetic Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Florida State University on 2026-05-20.