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Focused Ultrasound Therapy for Schizophrenia
Study Summary
This trial will test if a new treatment (PLIFUS) can reduce hallucinations and delusions in people with schizophrenia. 12 people will receive 1-3 sessions of PLIFUS or sham treatment. Results will show effectiveness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have been experiencing severe symptoms of psychosis for at least 4 weeks.You have been diagnosed with a mood disorder or other mental health condition, except for schizophrenia, schizoaffective disorder, or schizophreniform disorder.I am not pregnant, nursing, or planning to become pregnant and will use birth control during the study.You are currently addicted to or dependent on drugs or alcohol, except for nicotine and THC (found in marijuana).You have consumed more than four alcoholic drinks in the past day or used recreational drugs in the past two days.You have had thoughts of hurting yourself or have made a plan to hurt yourself in the past 6 months, or you have a history of attempting suicide.You have a significant problem with using cannabis.I have fainted in the last 6 months.You have a device called a neurostimulator implanted in your body.I do not have a major illness or condition affecting my brain.I have had brain surgery in the past.I do not have skin conditions at the intended treatment areas.You have a cochlear implant, which is a device that helps with hearing loss.I have been diagnosed with schizophrenia or schizoaffective disorder.My antipsychotic medication dose has been stable for 4 weeks, or I plan not to start any until after the study.
- Group 1: Pulsed Low-Intensity Focused Ultrasound (PLIFUS), then Sham
- Group 2: Sham, then Pulsed Low-Intensity Focused Ultrasound (PLIFUS)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this research involve participants aged 75 and younger?
"This trial has a limited age range of 18 to 50. By contrast, those under the age of 18 have access to 46 different studies while people over 65 years old can join 165 trials."
Does my profile qualify me to sign up for this study?
"This trial is seeking 12 individuals with schizoaffective disorder aged 18-50. The key requirements for successful enrolment are that the patient must exhibit current psychosis, established by a score of >4 on one or more BPRS items; have been diagnosed via SCID; remain stable in terms of antipsychotic medication if taking any; and for those assigned female at birth - demonstrate a negative pregnancy test result and abstain from conceiving during their participation in the study."
Are patients able to apply for this research exploration?
"According to info presented on clinicaltrials.gov, this investigation is not presently accepting candidates as it was last updated December 1st 2022. Nonetheless, there are 335 other trials that require the assistance of participants at the present time."
Has the FDA sanctioned Sham, then Pulsed Low-Intensity Focused Ultrasound (PLIFUS) for public use?
"The safety profile of Sham and Pulsed Low-Intensity Focused ultrasound (PLIFUS) has been graded at a 2, given that the clinical trials conducted to date have only collected evidence on its safety but not efficacy."
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