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N/A Completed N=9 Randomized Triple-blind Supportive Care

Improving Neurocognitive Deficits and Function in Schizophrenia With Transcranial Magnetic Stimulation

Source: ClinicalTrials.gov NCT03037983 ↗
Enrolled (actual)
9
Serious AEs
11.1%
Results posted
Aug 2020
Primary outcomePrimary: Change in Working Memory Function — -7.28; -5.9 % change in Working Memory Task Accuracy — p=.849

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Working Memory Function
-7.28; -5.9 .849
PRIMARY
Change in Neurophysiologic Function
0; 0
PRIMARY
Change in Level of Everyday Functioning
0; -.5 .782
PRIMARY
Change in General Cognitive Ability
-.104; .505

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03037983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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