rTMS as a Probe of Episodic Memory Neurocircuitry in Schizophrenia (rTMS-EM)
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, psychosis, early phase psychosis, rTMS
Eligibility Criteria
Inclusion Criteria:
- Between 18 and 40 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 DSM-5 (SCID-5) diagnosis of schizophrenia
Clinical stability defined by:
- Subjects must not have experienced an 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 new antipsychotic medication)
Exclusion Criteria:
- Lifetime history of a seizure, excluding febrile seizures and those induced by substance withdrawal
- First degree relative with idiopathic epilepsy or other seizure disorder
- History of significant neurological illness
- History of head trauma as defined by a loss of consciousness or a post-concussive syndrome
- Pregnant or breast feeding
- Known IQ < 70 based on subject report
- Current acute, serious, or unstable medical conditions
- Metallic objects planted in or near the head, including implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, 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 DSM-5 diagnosis of alcohol or drug use disorder (excluding nicotine or caffeine)
- Subjects who require concomitant treatment with prohibited medication, as specified in Attachment 2
Sites / Locations
- IU Center for Neuroimaging
- Prevention and Recovery Center for Early Psychosis
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
1 Hz rTMS Stimulation first, then 20 Hz rTMS Stimulation, then sham rTMS
1 Hz rTMS Stimulation first, then sham rTMS, then 20 Hz rTMS Stimulation
20 Hz rTMS Stimulation first, then 1 Hz rTMS Stimulation, then sham rTMS
20 Hz rTMS Stimulation first, then sham rTMS, then 1 Hz rTMS Stimulation
sham rTMS first, then 1 Hz rTMS Stimulation, then 20 Hz rTMS Stimulation
sham rTMS first, then 20 Hz rTMS Stimulation, then 1 Hz rTMS Stimulation
Subjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
Subjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
Subjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
Subjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
Subjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
Subjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.