Focused Ultrasound Modulation of the Globus Pallidus Interna in Schizophrenia

Prior treatment

• Current or recent suicidal ideation-- suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 6 months prior to screening or subjects who represent a significant risk of suicide in the opinion of the investigator or a history of suicide attempt.
• Contraindication to MRI: Metal implants, pacemaker, or other metal in the body or piercings that cannot be removed, or claustrophobia. Individuals with tattoos will be excluded from imaging if tattoos cover more than 5% of the body surface, if a tattoo is greater than 20 cm, or if a tattoo is located on the face, neck or genitals. Individuals with a contraindication to MRI may participate in the trial but will be excluded from the elective MRI component.
• A history or brain surgery .
• Implanted medication infusion device.
• Cochlear implants.
• The consumption of more than four alcoholic units within 24 hours before participation or any recreational drugs within 48 hours before participation.

Other illness

• Current substance abuse / dependence for substances other than nicotine and THC, (i.e. alcohol, amphetamines, barbiturates, etc.)
  • A positive urine toxicology screen (excluding THC, tricyclic antidepressants, or benzodiazepines (if prescribed).
  • Moderate or severe cannabis use disorder.
• Diagnosis of major mood disorder or other Axis I disorder other than schizophrenia, schizoaffective disorder or schizophreniform disorder.
• History of violence assessed by the Buss-Perry Aggression Questionnaire 45 and defined by violent physical contact or threat with a weapon.
• Significant medical or neurological illness by history or physical exam, including seizure disorder, history of loss of consciousness lasting more than 30 minutes related to head trauma or intellectual developmental disorder.
• History of syncopal episode within the past 6 months.
• A cardiac pacemaker or intra-cardiac lines.
• Skin disease at intended stimulation sites

Other

• Pregnant or nursing or positive urine pregnancy test.
• An implanted neurostimulator.
• Implanted metal devices or large ferromagnetic fragments in the head or upper body (excluding dental wire), or jewelry/piercing that cannot be removed.

• Must report current psychosis, as defined by a score of \> 4 on one of the following psychosis items on the Brief Psychiatric Rating Scale (BPRS): suspiciousness, hallucinations, unusual thought content, or grandiosity continuously for at least 4 weeks.
• Must have a diagnosis of either schizophrenia or schizoaffective disorder as established by a Structured Clinical Interview for DSM-V (SCID).
• If taking antipsychotic medication, the dose must be unchanged for at least 4 weeks prior to randomization. If not taking antipsychotic medication, must be intending not to start medication until after completion of the study (approximately 2 weeks)-this decision must be judged to be appropriate by the research psychiatrist and by the participant's clinician.
• If assigned female at birth and of childbearing potential, patients must
  • have a negative urine pregnancy test (all participants assigned female at birth regardless of childbearing potential will be required to submit a pregnancy test), AND;
  • not be nursing or planning a pregnancy for the duration of the study through 30 days after the last sonication visit, AND;
  • be abstinent or willing to use a reliable method of birth control from the Screening Visit and continue with the same method until termination from the study.