rTMS in First Episode Psychosis

NCT02131129 | Completed Results DMC

• 1 other identifier: 1401416429
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

This study proposes to examine the application of rTMS for the treatment of cognitive dysfunction in FEP. This is an important population for study because if effective, rTMS may represent a preventative treatment for the development of social and vocational impairment that is associated with cognitive dysfunction in schizophrenia. This study will also seek to refine the understanding of the brain circuitry that mediates the potential pro-cognitive effects of rTMS through the use of functional magnetic resonance imaging (fMRI) at baseline and following the course of rTMS administration.

Conditions

Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder

Keywords

schizophrenia; schizophreniform disorder; schizoaffective disorder; first episode; psychosis; cognition

Outcome Measures

Primary Outcomes (2)

• Cognitive Performance

  rTMS effectiveness in improving cognitive performance as measured by the Brief Assessment of Cognition in Schizophrenia (BACS) composite score. The BACS is a battery specifically designed to measure treatment-related changes in cognition, and has alternate forms, thus minimizing practice effects. The battery includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed, and generates a composite score that is calculated by summing t-scores derived by comparisons with a normative sample of 404 healthy controls. The six brief assessments' t-scores, are summed, and averaged to provide a composite t-score. The composite score min and max are between -43 and 100. A higher score indicating better cognitive performance. The composite score is reported as a change score relative to baseline for both.

  For within-group comparisons, scores at V13 (day 15) and V14 (follow-up two weeks after V13) were compared to baseline

• Cortical Activation

  effects of rTMS on cortical activation using fMRI during working memory and episodic memory tasks

  Change from Baseline (day 1) to Visit 13 (day 15)

Secondary Outcomes (4)

• Cognitive Performance

  14 days

• Cognitive Performance

  14 days

• Symptoms

  For within-group comparisons, scores at V13 (day 15) and V14 (follow-up two weeks after V13) were compared to baseline

• Negative Symptoms

  Assessed at Baseline (day 0), Midpoint (day 8), and Endpoint (day 15)

Study Arms (2)

rTMS

EXPERIMENTAL

The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).

Device: rTMS

Sham

SHAM COMPARATOR

The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).

Device: Sham Comparator

Interventions

rTMS DEVICE

The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day). Ten sessions over a two week duration

Also known as: NeuroStar

rTMS

Sham Comparator DEVICE

The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day). Ten sessions over a two week duration

Also known as: NeuroStar

Sham

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age at study entry
• Male or female
• DSM IV-TR Diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder as confirmed by Structured Clinical Interview for DSM-IV-TR (SCID)44
• Subjects in their first-episode of psychosis, defined as the onset of clinically significant psychotic symptoms within the past five years as determined by first medical record documentation of these conditions
• BACS composite t-score of 40 or less at baseline assessment
• Clinical stability as defined by:
• CGI-S score of less than or equal to 4 (moderately ill) at randomization AND
• 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 any new antipsychotic medication).
• Able to give informed consent
• Subjects must be willing and able to adhere to study schedule
• Outpatient or Inpatient treatment status
• Female subjects of childbearing potential must test negative for pregnancy at screening and baseline visit

You may not qualify if:

• Life-time history of a seizure, excluding febrile seizures and those induced by substance withdrawal
• 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
• 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, 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 deemed significant by PI
• Pregnancy or breast feeding
• Known IQ \< 70 based on medical history
• Current DSM-IV-TR diagnosis of alcohol or drug dependence (excluding nicotine or caffeine)
• Subjects with current acute, serious, or unstable medical conditions, including, but not limited to: inadequately controlled diabetes, asthma, 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.
• Subjects with contraindications to MRI or otherwise unable to tolerate MRI procedure
• 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
• 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 who require concomitant treatment with prohibited medication, as specified in Attachment 2
• Subjects with a history of electroconvulsive therapy

Sponsors & Collaborators

• Indiana University: lead
• Neuronetics: collaborator

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

Results Point of Contact

• Title: Dr. Michael Francis
• Organization: IndianaU

mmfranci@iupui.edu

317-880-8495

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Psychiatrist

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: May 6, 2014
• Study Start: April 30, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 19, 2023
• Results First Posted: January 29, 2019

Record last verified: 2023-03

Locations

US (2)