Focused Ultrasound Modulation of the Globus Pallidus Interna in Schizophrenia

Exclusion Criteria

• •1. 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.
• •2. Diagnosis of major mood disorder or other Axis I disorder other than schizophrenia, schizoaffective disorder or schizophreniform disorder.
• •3. 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.
• •4. History of violence assessed by the Buss-Perry Aggression Questionnaire 45 and defined by violent physical contact or threat with a weapon.
• •5. Pregnant or nursing or positive urine pregnancy test.
• •6. 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.
• •7. 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.
• •8. A history or brain surgery .
• •9. History of syncopal episode within the past 6 months.
• •10. A cardiac pacemaker or intra-cardiac lines.
• •11. An implanted neurostimulator.
• •12. Implanted medication infusion device.
• •13. Implanted metal devices or large ferromagnetic fragments in the head or upper body (excluding dental wire), or jewelry/piercing that cannot be removed.
• •14. Cochlear implants.
• •15. Skin disease at intended stimulation sites
• •16. The consumption of more than four alcoholic units within 24 hours before participation or any recreational drugs within 48 hours before participation.