rTMS for Working Memory Deficits in Schizophrenia

NCT01880255 | Completed

• 1 other identifier: 057/2013
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Repetitive Transcranial Magnetic Stimulation; Schizophrenia; Cognition; Working Memory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Brain Imaging Changes

  4 weeks

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

Active treatment will be delivered at an intensity that is 90% of the resting motor threshold (RMT). Stimulation will be delivered at 20 Hz with 25 stimulation trains of 30 stimuli each (i.e., 750 stimuli) and an intertrain interval of 30 sec. Treatment will be applied in sequential order bilaterally to the left and right dorsolateral prefrontal cortex (DLPFC). The order of bilateral stimulation (i.e. right then left or left then right) will be held constant for all 20 treatments. Intervention: Device: Repetitive Transcranial Magnetic Stimulation

Device: Repetitive Transcranial Magnetic Stimulation

Sham rTMS

SHAM COMPARATOR

Sham stimulation will be delivered using the same stimulation parameters and at the site of active treatment, but with only the side-edge resting on the scalp. The coil will be angled 45 degrees away from the skull in a single-wing tilt position. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects. Intervention: Device: Repetitive Transcranial Magnetic Stimulation

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

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

Also known as: MagPro X100 Series (Medtronic A/S, Copenhagen, Denmark)

Active rTMS; Sham rTMS

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Location

Related Publications (1)

• Voineskos AN, Blumberger DM, Schifani C, Hawco C, Dickie EW, Rajji TK, Mulsant BH, Foussias G, Wang W, Daskalakis ZJ. Effects of Repetitive Transcranial Magnetic Stimulation on Working Memory Performance and Brain Structure in People With Schizophrenia Spectrum Disorders: A Double-Blind, Randomized, Sham-Controlled Trial. Biol Psychiatry Cogn Neurosci Neuroimaging. 2021 Apr;6(4):449-458. doi: 10.1016/j.bpsc.2020.11.011. Epub 2020 Nov 28.

  PMID: 33551284 DERIVED

Related 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

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Aristotle Voineskos, MD, PHD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Slaight Family Centre for Youth in Transition; Head, Kimel Family Imaging-Genetics Laboratory

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 18, 2013
• Study Start: June 1, 2013
• Primary Completion: January 7, 2019
• Study Completion: January 7, 2019
• Last Updated: July 11, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)