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NCT Number: NCT01880255

rTMS for Working Memory Deficits in Schizophrenia

In this study, the investigators will be examining the effects of repetitive transcranial magnetic stimulation (rTMS) on memory deficits in individuals with schizophrenia and schizoaffective disorder. Half of the study participants will be chosen by chance to receive active rTMS stimulation while half will be chosen by chance to receive sham rTMS. Sham rTMS will feel the same as active rTMS only there will be no direct brain stimulation. This is necessary to ensure that active rTMS is efficacious in the enhancement of memory in individuals with schizophrenia. Based on results from a recently published pilot study, the investigators propose that active rTMS treatment will result in a significant improvement in working memory performance compared to sham rTMS treatment.

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Key information

Conditions

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

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

About this study

This study is a randomized, double blind, sham controlled study to evaluate the efficacy of repetitive transcranial magnetic stimulation as a treatment for working memory deficits in individuals with schizophrenia or schizoaffective disorder between 18 and 59 years of age. The study duration is approximately 3 months, with the rTMS sessions lasting for 4 weeks, 5 times a week, for about 1 hour each. Several scales will be used to assess symptom severity as part of the clinical assessment. Cognition will be assessed using a validated battery and the N-back task.

This study also involves a type of brain imaging known as magnetic resonance imaging (MRI) at the beginning and at the end of the 4 weeks of daily rTMS to better understand the effects of rTMS on brain structure and function. Investigators will measure the size and connections of different parts of the brain to assess brain structure and blood flow while you are completing some basic tasks to assess brain function. We will also collect two blood samples (before and after rTMS treatment) to see if certain proteins change in response to treatment. Finally, an analysis of genetic material will be conducted to see if genes play a role in differences in how people respond to treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Between 18 and 59 years of age
  • Current diagnosis of Schizophrenia or Schizoaffective Disorder
  • Able to provide written informed consent
  • Fluency in the English Language

Exclusion criteria

  • Have a history of substance abuse or dependence in the last 6 months
  • Have a concomitant major and unstable medical or neurologic illness
  • Have a history of seizures or have a first degree relative with a history of a seizure disorder
  • Current pregnancy or a plan to become pregnant during the duration of the study
  • Clinical instability: determined by treating physician
  • Have received electroconvulsive therapy (ECT) within the last year
  • Have a history of repetitive transcranial magnetic stimulation (rTMS)
  • Are taking a benzodiazepine at a dose greater than Lorazepam 2mg or equivalent
  • Are taking any non-benzodiazepine anticonvulsant
  • Have a cardiac pacemaker, cochlear implant, implanted electronic device or non-electric metallic implant

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

rTMS is a non-invasive procedure involving the use of magnetic fields to stimulate nerve cells.

Other names: MagPro X100 Series (Medtronic A/S, Copenhagen, Denmark)

Primary outcomes

  1. Performance on the N-back working memory task

    Time frame: 4 weeks

    The primary outcome measure will be the performance on the N-back working memory task. Specifically, we will evaluate if rTMS results in a change in percent of correct responses in the N-back task.

    Note: the N-back is a continuous performance task that is commonly used to measure attention and working memory.

Secondary outcomes

  1. Brain Imaging Changes

    Time frame: 4 weeks

    For brain imaging we will test for group differences using: (1) cortical thickness (2) volumetric measures, (3) diffusion based measures. Statistical tests measuring these differences will be conducted at baseline and following the final rTMS treatment session. We will control for possible effects of neuroleptic medication on MRI measures by regressing mean dosage levels multiplied by number of years on medication, for each of five classes of medication (typical neuroleptics, atypical neuroleptics, antiparkinsonian anticholinergics, lithium, benzodiazepines)

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Working Memory Deficits in Schizophrenia and Effects on Brain Structure

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jun 18, 2013
Registry last updated
Jul 11, 2019

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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