rTMS in First Episode Psychosis
Condition: Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Interventional

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.
    

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.
    

Intervention name(s): rTMS; Sham Comparator
Intervention type(s): Device; Device
Intervention description(s): 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; 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 intervention name(s): NeuroStar; NeuroStar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; schizophreniform disorder; schizoaffective disorder; first episode; psychosis; cognition