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RECRUITINGINTERVENTIONAL

Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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) -

Treatments Being Tested

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.

Locations (1)

Florida State University
Tallahassee, Florida, United States