NCT06544408 · Florida State University
Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation
What this study is about
This study will test the clinical effectiveness of an accelerated TMS (accel-TMS) protocol that rapidly addresses PTSD symptoms with 1 week (25 sessions over 5 days) of condensed treatment.
View original scientific description
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.
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.
Primary outcome measures
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.
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.
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.
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
Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine superior symptom reduction
Time frame: Assessment of symptoms during the preceding week.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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) -
Where
- Tallahassee, Florida
Collaborators
United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 20, 2026 · Source of record for eligibility and locations