rTMS for Working Memory Deficits in Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880255
• Other study ID #: 057/2013
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: January 7, 2019

Study information

• Verified date: July 2019
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 7, 2019
• Est. primary completion date: January 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Memory Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation
rTMS is a non-invasive procedure involving the use of magnetic fields to stimulate nerve cells.

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance on the N-back working memory task	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.	4 weeks
Secondary	Brain Imaging Changes	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)	4 weeks

External Links

•   Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital. It is fully affiliated with the University of Toronto, and is a PAHO/WHO Collaborating Centre