A sham-controlled pilot trial of focused ultrasound modulation of the globus pallidus interna in schizophrenia

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Schizoaffective
    Schizophrenia
  • Age: Between 18 Year(s) - 55 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Males and females 18 to 55 years of age, inclusive, at time of informed consent.
    2. Must have a diagnosis of either schizophrenia or schizoaffective disorder.
    3. Must report current psychosis symptoms for at least 4 weeks.
    4. 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—this decision must be judged to be appropriate by the research psychiatrist and by the participant’s clinician.
    5. If assigned female at birth and of childbearing potential, patients must:
      • a) Have a negative urine pregnancy test (all participants assigned female at birth regardless of childbearing potential will be required to submit a pregnancy test).
      • b) Not be nursing or planning a pregnancy for the duration of the study through 30 days after the last sonication visit.
      • c) 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.

You may not be eligible for this study if the following are true:

    1. Current substance abuse / dependence for substances other than nicotine and THC, (i.e., alcohol, amphetamines, barbiturates, etc.).
      • a) A positive urine toxicology screen (excluding THC, tricyclic antidepressants, or benzodiazepines (if prescribed).
      • b) Moderate or severe cannabis use disorder.
    2. Diagnosis of major mood disorder or other Axis I disorder other than schizophrenia or schizoaffective disorder.
    3. Suicidal ideation with intent or plan in the 6 months prior to screening or subjects who represent a significant risk of suicide in the opinion of the investigator or have a history of suicide attempt.
    4. History of violence, defined by violent physical contact or violent threat.
    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. Metal implants, such as a cardiac pacemaker, intra-cardiac lines, neurostimulator, medication infusion device, jewelry/piercings that cannot be removed, and/or any other metal in the body that cannot be removed.
    8. Claustrophobia.
    9. History of syncopal episode within the past 6 months.
    10. A history of brain surgery.
    11. Cochlear implants.
    12. Skin disease at intended stimulation sites.
    13. The consumption of more than four alcoholic units within 24 hours before participation or any recreational drugs within 48 hours before participation.



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