Post Traumatic Stress Disorder, Traumatic Brain Injury
Conditions
Keywords
PTSD, TMS, Transcranial Magnetic Stimulation
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.
Interventions
DEVICECool 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.
DEVICECool 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.
DEVICECool 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).
DEVICECool 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).
DEVICECool 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.
Sponsors
Florida State University
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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) -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine left dl-PFC accel-TMS efficacy | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 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 |
| Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine added benefit during Extension | 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 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). |
Countries
United States
Contacts
CONTACTIsabelle M Taylor, MA
CONTACTKevin A Johnson, PhD
PRINCIPAL_INVESTIGATORFrank A Kozel, MD
Florida State University
Outcome results
None listed