Clinical trial NCT03037983: Improving Neurocognitive Deficits and Function in Schizophrenia With Transcranial Magnetic Stimulation
Official title: Improving Neurocognitive Deficits and Function in Schizophrenia With Transcranial Magnetic Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Transcranial magnetic stimulation
Electroencephalography
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Stanford University
name: University of South Carolina
First posted: 2017-01-31
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether repetitive transcranial magnetic stimulation (rTMS) is effective in remediating cognitive deficits while also improving functionality in Veterans with schizophrenia.

Detailed description: High-frequency, repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC), the dysfunctional brain region most implicated in cognitive deficits in schizophrenia, has recently been shown to improve cognition in non-Veteran samples with schizophrenia. The investigators' goal is to confirm the efficacy of this treatment modality to remediate cognitive deficits and improve functionality in Veterans with schizophrenia, as well as to gain a better understanding of the neural mechanisms responsible for cognitive deficits and their remediation. The investigators propose conducting a small-scale study to generate pilot data supporting the feasibility of conducting rTMS with Veterans and the effectiveness of rTMS in this population. In addition, the investigators will conduct neurophysiologic experiments to test whether certain neural maker of abnormal brain function improves with rTMS.

Eligibility criteria: Inclusion Criteria:

* SCID (Structured Clinical Interview for DSM Disorders) confirmed diagnosis of Schizophrenia or Schizoaffective Disorder
* Stable medication regimen (no change in dose or agents within the 2 weeks prior to study entry and throughout the duration of the study)
* Stable social environment and housing to enable regular attendance at clinic visits
* Ability to undergo cognitive testing, EEG scans and rTMS
* IQ (intelligence quotient) \> 80 (WASI full scale score)
* In general good medical health
* Is in treatment with a psychiatrist and/or primary care physician within the VHA (Veteran's Health Administration) system

Exclusion Criteria:

* Pregnant or lactating female
* History of prior adverse reaction to TMS
* On medications known to significantly lower seizure threshold, e.g.:

  * clozapine
  * chlorpromazine
  * clomipramine
* History of seizures or conditions known to substantially increase risk for seizures
* Implants or medical devices incompatible with TMS
* Acute or unstable chronic illness that would affect participation or compliance with study procedures, e.g.:

  * unstable angina
* Substance abuse/dependence (not including caffeine or nicotine) within one-month period prior to study entry or during study participation
* Unstable psychiatric symptoms that precludes consistent participation in the study, e.g.:

  * active current suicidal intent or plan
  * severe psychosis
* History of loss of consciousness greater than 15 minutes due to head injury.
* Participation in another concurrent clinical trial
* Patients with prior exposure to rTMS
* Have a mass lesion, cerebral infarct or other active central nervous system disease, or history of traumatic brain injury

Primary outcomes:
measure: Change in Working Memory Function
timeFrame: before treatment and after 6-week treatment
measure: Change in Neurophysiologic Function
timeFrame: before treatment and after 6-week treatment
measure: Change in Level of Everyday Functioning
timeFrame: before treatment and after 6-week treatment
measure: Change in General Cognitive Ability
timeFrame: before treatment and after 6-week treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Jong H. Yoon, MD
role: PRINCIPAL_INVESTIGATOR
References: