Accelerated TMS in Psychosis (NCT05567848) | Clinical Trial Compass
SuspendedPhase 1/2
Accelerated TMS in Psychosis
Stopped: Paused for data analysis
United States20 participantsStarted 2022-11-29
Plain-language summary
This study is to determine the tolerability and efficacy of an accelerated schedule of Transcranial Magnetic Stimulation for treating symptoms of psychotic disorders such as schizophrenia.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 18-65 years
* Diagnosis of a psychotic disorder (i.e. schizophrenia or schizoaffective disorder) or have been identified as being at clinical high risk for developing a psychotic disorder.
* Must be able to read, speak and understand English
* Must be judged by study staff to be capable of completing the study procedures
* Participants will be in stable outpatient treatment with no recent (within the past 30 days) hospitalizations or changes in their medication regimens.
Exclusion Criteria:
* Diagnostic and Statistical Manual 5 diagnosis of moderate substance use disorder within the past month
* Medications will be reviewed by the PI and a decision about inclusion will be made based on the participant's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other central nervous system active drugs. Current published TMS guidelines do not preclude specific medications in the setting of TMS(Rossi et al., 2021)
* Conditions that might result in increased risks of side effects or complications from rTMS or MRI, including:
* Intracranial pathology from a known genetic disorder (e.g., Neurofibromatosis 1, tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology;
* History of fainting spells of unknown or undetermined etiology that might constitute seizures
* History of multiple sei…
What they're measuring
1
Tolerability of accelerated TMS
Timeframe: 5 days of multiple session of TMS per day