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Completed

NCT Number: NCT03037983

Improving Neurocognitive Deficits and Function in Schizophrenia With Transcranial Magnetic Stimulation

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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between.

Other names: rTMS

SHAM

Device

Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject.

Primary outcomes

  1. Change in Working Memory Function

    Time frame: before treatment and after 6-week treatment

    Changes in scores for working memory performance accuracy will serve as dependent measure for testing the hypothesis that rTMS improves working memory. Working memory performance was assessed using a non-standardized task developed in house, which is basically a Sterberg style delayed response task in which memoranda are displayed and are to be remembered across a short delay period. The hypothesis will be supported if the investigators find greater working memory difference in the active compared to the sham-rTMS-treated groups as revealed by t-tests and two-sided tests at an alpha level of 0.05. Scores will be reported as a change in percent accuracy during this working memory task, where higher percent accuracy is better and scores range from -100% to 100%.

  2. Change in Neurophysiologic Function

    Time frame: before treatment and after 6-week treatment

    Gamma oscillation is viewed as a measure of neurophysiologic function. The investigators will be conducting task-evoked electroencephalography (EEG) to measure gamma oscillation before and after rTMS. It is predicted that the intervention will improve gamma oscillations.

  3. Change in Level of Everyday Functioning

    Time frame: before treatment and after 6-week treatment

    Changes in Global Functioning Scale scores (GF) will serve as dependent measure for testing the hypothesis that rTMS improves functioning. The hypothesis will be supported if the investigators find greater GF-difference in the active compared to the sham-rTMS-treated groups as revealed by t-tests and two-sided tests at an alpha level of 0.05.

    Scale's values range from a minimum score of 1 to a maximum score of 10, with a higher score means better functioning.

  4. Change in General Cognitive Ability

    Time frame: before treatment and after 6-week treatment

    Changes in Brief Assessment of Cognition (BACS) score will serve as a dependent measure for testing the hypothesis that rTMS improves cognitive functioning. The hypothesis will be supported if the investigators find greater GF-difference in the active compared to the sham-rTMS-treated groups as revealed by t-tests and two-sided tests at an alpha level of 0.05. Data will be reported as change in Z-score on the scale, where a higher value means a better outcome, with scores ranging from -3 to 3.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Stanford University
  • University of South Carolina

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 31, 2017
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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