Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation

NCT06544408 | Recruiting FDA Device

• 2 other identifiers: STUDY00005179CDMRP-TP230396
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Traumatic Brain Injury; Post Traumatic Stress Disorder

Keywords

PTSD; TMS; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (3)

• Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine left dl-PFC accel-TMS efficacy

  CAPS-V is a 30-item clinical interview used to diagnose PTSD as well as monitor PTSD symptoms. Questions address the traumatic event(s), symptom duration, subjective distress, impact on functioning, dissociation, and symptom improvement since last evaluation. During the Acute Phase, CAPS-V will be used to determine the rapid efficacy of left dl-PFC accel-TMS compared to sham accel-TMS at approximately one-week post-treatment.

  Assessment of symptoms during the preceding week.

• Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine dm-PFC accel-TMS efficacy

  A 30-item clinical interview used to diagnose PTSD as well as monitor PTSD symptoms. Questions address the traumatic event(s), symptom duration, subjective distress, impact on functioning, dissociation, and symptom improvement since last evaluation. During the Acute Phase, CAPS-V will be used to determine the rapid efficacy of dm-PFC accel-TMS compared to sham accel-TMS at approximately one-week post-treatment

  Assessment of symptoms during the preceding week.

• Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine superior symptom reduction

  A 30-item clinical interview used to diagnose PTSD as well as monitor PTSD symptoms. Questions address the traumatic event(s), symptom duration, subjective distress, impact on functioning, dissociation, and symptom improvement since last evaluation. During the Extension Phase, CAPS-V will be used to determine whether an additional week of left dl-PFC accel-TMS provides superior reduction of PTSD symptoms compared to one week of left dl-PFC accel-TMS.

  Assessment of symptoms during the preceding week.

Secondary Outcomes (3)

• Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to characterize durability of accel-TMS effects

  Assessment of symptoms during the preceding week before each follow-up visit.

• Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine superior outcomes between active left dl-PFC and active dm-PFC accel-TMS

  Assessment of symptoms during the preceding week.

• Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine added benefit during Extension

  Assessment of symptoms during the preceding week.

Study Arms (5)

Arm 1: active left dl-PFC accel-TMS

ACTIVE COMPARATOR

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

Device: Cool B70 AP Coil - Active (dl-PFC)

Arm 2:active dm-PFC accel-TMS

ACTIVE COMPARATOR

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

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

Arm 3 - sham accel-TMS dl-PFC

SHAM COMPARATOR

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

Device: Cool B70 AP Coil- Sham (dl-PFC)

Arm 4: sham accel -TMS dm-PFC

SHAM COMPARATOR

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

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

Arm 5

ACTIVE COMPARATOR

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

Device: Cool B70 Treatment Coil - Active Only

Interventions

Cool B70 AP Coil - Active (dl-PFC) 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 1: active left dl-PFC accel-TMS

Cool B70 AP Coil- Sham (dl-PFC) 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 3 - sham accel-TMS dl-PFC

Cool D-B80 AP Coil - Active (dm-PFC) 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 2:active dm-PFC accel-TMS

Cool D-B80 AP Coil - Sham (dm-PFC) 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 4: sham accel -TMS dm-PFC

Cool B70 Treatment Coil - Active Only 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.

Arm 5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 18 years to 65 years old.
• Meets DSM-5 criteria for PTSD with a PCL-5 score \> 33
• 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.
• 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

You may not qualify if:

• Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).
• Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment.
• Dementia or other cognitive disorder making unable to engage in treatment.
• Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness that precludes safe participation in trial.
• Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide.
• OCD cannot be the primary disorder but can have OCD symptoms.
• Inability to stop taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)
• Current, planned, or suspected pregnancy
• 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.)
• Severe Traumatic Brain Injury
• We will exclude non-English speakers because of the need for rapid communication during the delivery of treatments.
• 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).
• Prior known active TMS of dorsolateral prefrontal cortex or dorsomedial prefrontal cortex or electroconvulsive therapy (ECT) -

Sponsors & Collaborators

• Florida State University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Frank A Kozel, MD

  Florida State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle M Taylor, MA

CONTACT

850-644-2824; fsun@fsu.edu

Kevin A Johnson, PhD

CONTACT

850-644-2824; fsun@fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding Procedures The participants, PI, Research Staff involved in TMS treatment, and staff performing the study procedures will be blinded to the participant's dl-PFC protocol assignment throughout the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)