Schizophrenia Clinical Trial
— rTMS-EMOfficial title:
Repetitive Transcranial Magnetic Stimulation (rTMS) as a Probe of Episodic Memory (EM) Neurocircuitry in Schizophrenia
Verified date | July 2023 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This will be a single site pilot study. 30 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 enrolled. Prior to randomization (Session 1), subjects will undergo Functional Magnetic Resonance Imaging (fMRI) during Episodic Memory (EM) and Resting State (RS) paradigms. This baseline scan will also include a high-resolution structural sequence for neuronavigation purposes. Then on three separate days each occurring one-week apart, subjects will receive one session of inhibitory (1 Hertz [Hz]) Repetitive Transcranial Magnetic Stimulation (rTMS), one session of excitatory (20 Hz) rTMS, and one sham stimulation session targeting the precuneus. The order of the three interventions will be randomized. Immediately following each rTMS or sham session, subjects will undergo repeat fMRI during EM and RS paradigms. The investigators will also examine the effect of rTMS on EM performance.
Status | Completed |
Enrollment | 25 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: 1. Between 18 and 40 years of age 2. Within 10 years of illness onset as defined by entry into treatment for psychotic symptoms 3. Able to give informed consent 4. Willing and able to adhere to the study schedule 5. Structured Clinical Interview for DSM-5 (SCID-5) diagnosis of schizophrenia 6. Clinical stability defined by: 1. 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 2. Antipsychotic treatment stability for at least 4 weeks prior to randomization (no change in antipsychotic dosing or addition of new antipsychotic medication) Exclusion Criteria: 1. Lifetime history of a seizure, excluding febrile seizures and those induced by substance withdrawal 2. First degree relative with idiopathic epilepsy or other seizure disorder 3. History of significant neurological illness 4. History of head trauma as defined by a loss of consciousness or a post-concussive syndrome 5. Pregnant or breast feeding 6. Known intelligence quotient (IQ) < 70 based on subject report 7. Current acute, serious, or unstable medical conditions 8. 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 9. Contraindications to Magnetic Resonance Imaging (MRI) or otherwise unable to tolerate MRI procedures 10. History of electroconvulsive therapy 11. Subjects taking clozapine 12. 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 13. 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 14. Current DSM-5 diagnosis of alcohol or drug use disorder (excluding nicotine or caffeine) 15. Subjects who require concomitant treatment with prohibited medication, as specified in Attachment 2 |
Country | Name | City | State |
---|---|---|---|
United States | IU Center for Neuroimaging | Indianapolis | Indiana |
United States | Prevention and Recovery Center for Early Psychosis | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Precuneus Functional Activation | Change in estimated beta coefficients for the Target vs. Foil contrast during scene recognition in the precuneus. Beta coefficients reflect the strength of the blood oxygen-level dependent (BOLD) signal during each condition.Target images are those previously shown to participants, and Foil images have not been previously shown, as participants indicate whether they have been shown images. A higher measure indicates that the intervention increased brain activity during recognition of previously shown scenes. | 1 day | |
Primary | Precuneus Functional Connectivity | Blood oxygen level dependent (BOLD) signal functional connectivity with the precuneus in the bilateral dorsolateral prefrontal cortex, hippocampus, and anterior cingulate cortex. Value is the mean Fisher's transform of the correlation of BOLD time-series in the precuneus with the BOLD time-series in other named regions. Higher values indicate greater connectivity with the precuneus following the intervention. Value of zero indicates no relationship (no connectivity). This value has no unit of measurement. | 1 day | |
Primary | Performance During In-scanner Episodic Memory Task | Percent accuracy (0-100%) on detecting whether an image shown during a scene recognition was among those shown during the previous five-minute session. Higher scores indicate better performance in recalling images. | 1 day |
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