FUS Neuromodulation for PTSD

• Males and non-pregnant females aged 20 - 65 years at time of enrollment.
• Able and willing to give informed consent.
• Diagnosis of PTSD according to DSM-5-TR criteria
• Prior treatment failure or partial response to at least one evidence-based therapy for PTSD (pharmacologic or psychotherapeutic).
• Currently are under the care of a psychiatrist or other mental health care provider and agrees to promptly inform the investigator or the study staff of any change in these providers.
• If on prescribed medication for the treatment of PTSD, or for any other underlying psychiatric conditions, must be on a stable dose (stable dose is defined as within the therapeutic range but does not require same exact dose) for ≥4 weeks prior to screening.
• If engaged in psychotherapy for the treatment of PTSD, or for any other underlying psychiatric condition, therapy must be stable and ongoing for ≥4 weeks prior to screening.
• Willing to not receive any other experimental treatment for PTSD during the study period.
• Willing to cooperate with the study requirements, including compliance with the regimen, admission requirements, completion of all study visits, and study assessments.
• Able to communicate sensations during the FUS procedure.
• Willing to undergo stress induction before, during, and/or after the procedure that may be triggered by trauma-related cueing.
• Participants of reproductive potential must have a negative pregnancy test and agree to use effective contraceptive methods while participating in the study.

A candidate will be excluded if they meet any of the following criteria:

• Unable to undergo MR-imaging because of non-MR compatible implants or if candidates are uncomfortable in small spaces (have claustrophobia).
• Clinically significant MRI abnormality indicative of a neurological condition or abnormality that may jeopardize the participant's safety, study conduct, or confound the participant's diagnostic assessments.
• Participants who are unable or unwilling to lay flat/sit and tolerate the required prolonged stationary position during treatment (approximately 1-2 hours).
• History of any clinically significant neurological disorder or condition (e.g., brain surgery in basal ganglion region, brain tumors, moderate to severe traumatic brain injury, medically uncontrolled epilepsy, or any others deemed clinically significant by the investigator).
• Use of medications that significantly lower the seizure threshold or interfere with neuromodulation safety, as determined by the study physician.
• Currently participating in another clinical investigation with an active treatment arm or participated in any experimental therapy (drug or biologic or device) within 3 months prior to Screening.
• A current or reasonably anticipated ongoing traumatic context, including violence, abuse, credible threats, stalking, exploitation, continued traumatic contact with a perpetrator, or an unsafe living environment, that would materially compromise the participant's safety or ability to participate in the study intervention or assessments.
• High Acute Risk of Suicide as determined clinically, including, but not limited to, current suicidal ideation, intent, or plan.
• High Acute Risk of Homicide as determined clinically, including, but not limited to, current homicidal ideation, intent, or plan.
• Clinically significant level of depression requiring further and/or imminent intervention as indicated by the Hamilton Depression Rating Scale
• Participant is pregnant/lactating or planning to be pregnant.
• Past or present diagnosis of schizophrenia or any psychotic disorder.
• Past or present diagnosis of a Personality Disorder-Cluster B.
• Current or ongoing legal issues that may interfere with study participation.