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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-TP230396 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| 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 |
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| 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 |
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| Arm 5 | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to characterize durability of accel-TMS effects | 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 Follow-Up Phase to characterize the durability of accel-TMS effects on PTSD symptoms at 1-month, 3-months, and 6-months post treatment. |
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Inclusion:
Exclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle M Taylor, MA | Contact | 850-644-2824 | fsun@fsu.edu | |
| Kevin A Johnson, PhD | Contact | 850-644-2824 | fsun@fsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Frank A Kozel, MD | Florida State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University | Recruiting | Tallahassee | Florida | 32306 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 22, 2025 | May 12, 2025 |
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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.
Extension phase, all participants will receive active left dl-PFC accel-TMS.
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| 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). |
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| 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. |
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| 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. |
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| 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. |
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| 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 | 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 to determine whether active left dl-PFC or active dm-PFC accel-TMS produces superior outcomes for PTSD symptoms | Assessment of symptoms during the preceding week. |
| Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine added benefit during Extension | 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 to determine whether an additional week of open left dl-PFC accel-TMS will provide added benefit to those participants that received active dm-PFC accel-TMS (i.e., targeting 2 brain regions versus 1 brain region). | Assessment of symptoms during the preceding week. |
| ICF_001.pdf |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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