Repetitive Transcranial Magnetic Stimulation (rTMS) Self-Referential Processing (rTMS-SRP)

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Schizophrenia, Schizo Affective Disorder

In brief

This will be a single site pilot study. 16 subjects with early phase psychosis (EPP), defined as medical record documentation of the onset of clinically significant psychotic symptoms within the past ten years, will be randomized 1:1 to double-blind treatment with 5 sessions of rTMS or sham stimulation directed at the bilateral precuneus over the course of 1 week. Subjects will undergo functional magnetic resonance imaging (fMRI) procedures, behavioral and cognitive assessments, and self-referential memory paradigm (SRMP) at baseline and immediately following the final rTMS or sham session. Contact with subjects will be conducted at two weeks after the end of study intervention for adverse event assessments. In the event new adverse events felt to be related to the study intervention have occurred following the termination of study procedures, subjects will be brought in for further safety assessments.

Key facts

Study ID

NCT04068857

Run by

Indiana University

People needed

0

Starts

2019-09-01

Expected to finish

2020-12-01

Last updated by the study team

2019-11-21

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between 18 and 45 years of age
• Within 10 years of illness onset as defined by entry into treatment for psychotic symptoms
• Able to give informed consent
• Willing and able to adhere to the study schedule
• Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (SCID-5) diagnosis of schizophrenia or schizoaffective disorder
• Clinical stability as defined by:
• Clinical Global Impression scale - Severity (CGI-S) score of less than or equal to 4 (moderately ill) at baseline AND
• No exacerbation of their illness within 4 weeks prior to randomization, leading to an intensification of psychiatric care in the opinion of the investigator. Examples of intensification of care include, but are not limited to: inpatient hospitalization, day/partial hospitalization, outpatient crisis management, or psychiatric treatment in an emergency room AND
• Antipsychotic treatment stability for at least 4 weeks prior to randomization (no change in antipsychotic dosing or addition of any new antipsychotic medication).

You may not qualify if…

• Lifetime history of a seizure, excluding febrile seizures and those induced by substance withdrawal
• First degree relative (that is, biological father, mother, brother, sister, or child) with idiopathic epilepsy or other seizure disorder
• History of significant neurological illness (including stroke, central nervous system (CNS) infection with persistent neurologic deficit, or other event deemed significant by PI)
• History of head trauma as defined by a loss of consciousness or a post-concussive syndrome
• Pregnant or breast feeding
• Known intelligence quotient (IQ) < 70 based on subject report
• Subjects with current acute, serious, or unstable medical conditions, including, but not limited to: inadequately controlled diabetes, asthma, chronic obstructive pulmonary disease (COPD), severe hypertriglyceridemia, recent cerebrovascular accidents, acute systemic infection or immunologic disease, unstable cardiovascular disorders, malnutrition, or hepatic, renal gastroenterological, respiratory, endocrine, neurologic, hematologic, or infectious diseases based on medical history or physical examination
• Metallic objects planted in or near the head, including implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, transcutaneous electrical nerve stimulation (TENS) unit, ventriculoperitoneal shunt, or cochlear implants
• Contraindications to MRI or otherwise unable to tolerate MRI procedures
• History of electroconvulsive therapy
• Subjects taking clozapine
• Subjects who have participated in a clinical trial with any pharmacological treatment intervention for which they received study-related medication in the 4 weeks prior to randomization
• Subjects considered a high risk for suicidal acts - active suicidal ideation as determined by clinical interview OR any suicide attempt in 90 days prior to screening
• Current SCID-5 diagnosis of substance use disorder (excluding nicotine or caffeine)
• Subjects who require concomitant treatment with prohibited medication, as specified in Attachment 2

Where it is running

• IU Center for Neuroimaging — Indianapolis, Indiana, United States
• Prevention and Recovery Center for Early Psychosis — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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