Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation

NCT ID: NCT06544408

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-06
• Study Completion Date: 2028-12-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Cool B70 AP Coil - Active (dl-PFC)

Intervention Type: DEVICE

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).

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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.

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

Group Type: SHAM_COMPARATOR

Cool B70 AP Coil- Sham (dl-PFC)

Intervention Type: DEVICE

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).

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

Group Type: SHAM_COMPARATOR

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

Intervention Type: DEVICE

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.

Arm 5

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

Group Type: ACTIVE_COMPARATOR

Cool B70 Treatment Coil - Active Only

Intervention Type: DEVICE

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.

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).

Intervention Type: 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).

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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) -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

F. Andrew Kozel

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank A Kozel, MD

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

Florida State University

Tallahassee, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Isabelle M Taylor, MA

Role: CONTACT

fsun@fsu.edu

850-644-2824

Kevin A Johnson, PhD

Role: CONTACT

fsun@fsu.edu

850-644-2824

Facility Contacts

Isabelle M Taylor, MA

Role: primary

fsun@fsu.edu

850-644-2824

Kevin A Johnson, PhD

Role: backup

fsun@fsu.edu

850-644-2824

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

CDMRP-TP230396

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00005179

Identifier Type: -

Identifier Source: org_study_id