rTMS in First Episode Psychosis (EmeraldThunder)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Indiana University
Sponsor:
Collaborator:
Neuronetics
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT02131129
First received: May 2, 2014
Last updated: NA
Last verified: May 2014
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizophreniform Disorder
Schizoaffective Disorder
Device: rTMS
Device: Sham Comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cortical Activation and Cognitive Performance During Repetitive Transcranial Magnetic Stimulation in First-Episode Psychosis: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • cognitive performance [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    rTMS effectiveness in improving cognitive performance as measured by the Brief Assessment of Cognition in Schizophrenia (BACS) composite score.

  • cortical activation [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    effects of rTMS on cortical activation using fMRI during working memory and episodic memory tasks


Secondary Outcome Measures:
  • cognitive performance [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    rTMS effectiveness in improving cognitive performance as assessed by the Trail Making Test-Part B

  • cognitive performance [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    rTMS effectiveness in improving cognitive performance as assessed by individual BACS battery sub-scales (verbal memory, digit sequencing, token motor, verbal fluency, symbol coding, tower of london)

  • symptoms [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    rTMS effectiveness in general symptomatology assessed by the Positive and Negative Syndrome Scale (PANSS)

  • negative symptoms [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    rTMS effectiveness in reducing negative symptoms as measured by the negative symptom assessment scale (NSA-16).


Estimated Enrollment: 20
Study Start Date: May 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rTMS
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

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

Other Name: NeuroStar
Sham Comparator: Sham
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

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

Other Name: NeuroStar

Detailed Description:

Schizophrenia is a chronic and disabling illness that typically begins in the late teen and early adult years.1 This illness is associated with significant impairments in areas such as independent living, social functioning, and vocational functioning.2 Indeed, only 10% of people with schizophrenia are employed, translating into annual lost wages of nearly 15 billion dollars.3,4 Schizophrenia also represents an important societal burden as this illness has been estimated to cost over 40 billion dollars each year in the United States alone.5

Repetitive transcranial magnetic stimulation (rTMS) is a novel treatment for neuropsychiatric illness. A non-invasive intervention, 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. The end result is altered neuronal activity in the area of the cerebral cortex where the rTMS is applied.12 rTMS is a safe and well-tolerated intervention that received FDA approval for treatment refractory major depressive disorder in 2008 and has since become commonly used in clinical practice.13

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-40 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 35 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02131129

Locations
United States, Indiana
Prevention and Recovery Center for Early Psychosis Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Nikki Mehdiyoun, MA    317-880-8495    rsparc@iupui.edu   
Principal Investigator: Michael Francis, MD         
Sub-Investigator: Alan Breier, MD         
Sub-Investigator: Emily Liffick, MD         
Sub-Investigator: Nikki Mehdiyoun, MA         
Sub-Investigator: Teresa Kulig, MS         
Sub-Investigator: Natalie Case, MS         
Sub-Investigator: Alexander Radnovich, MD, PhD         
Sub-Investigator: Amanda Roebel, MA         
Sub-Investigator: Thomas Hummer, PhD         
Sub-Investigator: Megan Gaunnac, BA         
Sub-Investigator: Steven Lindgren, BA         
Sub-Investigator: Fred Malloy, MA         
Sub-Investigator: Joan Showalter, MA         
Sub-Investigator: David Spradley, RN         
Sub-Investigator: Amy Visco, BA         
Sub-Investigator: Jenifer Vohs, PhD         
IU Center for NeuroImaging Active, not recruiting
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Neuronetics
  More Information

Additional Information:
No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT02131129     History of Changes
Other Study ID Numbers: 1401416429
Study First Received: May 2, 2014
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
schizophrenia
schizophreniform disorder
schizoaffective disorder
first episode
psychosis
cognition

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Disease
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014