N/A
N=24
rTMS as a Probe of Episodic Memory Neurocircuitry in Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT04182113 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Change in Precuneus Functional Activation — 0.0329; 0.067; -0.010 Beta coefficient change (Target vs Foil) — p=0.32
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 1 Hz rTMS Stimulation (Device); Sham rTMS Stimulation (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Precuneus Functional Activation |
0.0329; 0.067; -0.010 | 0.32 |
| PRIMARY Precuneus Functional Connectivity |
0.0657; 0.0482; 0.0566 | 0.038 sig |
| PRIMARY Performance During In-scanner Episodic Memory Task |
80.58; 76.63; 75.61 | 0.20 |
Summary
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.
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 intelligence quotient (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, Transcutaneous Electrical Nerve Stimulation (TENS) unit, ventriculoperitoneal shunt, or cochlear implants
- Contraindications to Magnetic Resonance Imaging (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
Data sourced from ClinicalTrials.gov (NCT04182113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.