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

NCT04068857 | Withdrawn DMC FDA Device

• 1 other identifier: 1904511224
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Schizophrenia; Schizo Affective Disorder

Keywords

schizophrenia; schizoaffective disorder; psychosis; early phase

Outcome Measures

Primary Outcomes (2)

• SRMP

  To determine the effects of HF rTMS targeting the bilateral precuneus on SRP as measured by a self-referential memory paradigm (SRMP)

  1 week

• Default mode network functional connectivity (DMN FC)

  To assess the effects of HF rTMS targeting the bilateral precuneus on DMN FC at rest

  1 week

Secondary Outcomes (4)

• Correlation between SRMP and DMN FC

  1 week

• SRMP and Scale to Assess Unawareness of Mental Disorder (SUM-D)

  1 week

• SRMP and Beck Cognitive Insight Scale (BCIS)

  1 week

• SRMP and Birchwood Insight Scale

  1 week

Study Arms (2)

rTMS

EXPERIMENTAL

Device: rTMS

Sham

SHAM COMPARATOR

Device: rTMS

Interventions

rTMS DEVICE

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that received FDA clearance for use in treatment resistant major depressive disorder in 2008 and has become commonly used in clinical practice. rTMS utilizes the application of a repetitively pulsed magnetic field over the scalp to induce an electric field within a discrete area of the cerebral cortex. This electric field results in altered ion flow across the neuronal cellular membrane and ultimately changes in neuronal polarization. rTMS enables investigators to manipulate brain activity in a targeted cortical region as well as downstream connectivity within an associated neuronal circuit. High frequency (HF) rTMS leads to facilitatory effects on brain excitability. Previous studies have demonstrated that administration of as little as a single train or a small number of trains are able to produce an immediate increase in cortical excitability.

Sham; rTMS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

IU Center for Neuroimaging

Indianapolis, Indiana, 46202, United States

Location

Prevention and Recovery Center for Early Psychosis

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Michael Francis, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 28, 2019
• Study Start: September 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)