The Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Working Memory
Treating Working Memory Deficits in Patients With Schizophrenia Using Repetitive Transcranial Magnetic Stimulation (rTMS)
1 other identifier
interventional
122
1 country
1
Brief Summary
Deficits in working memory (WM) performance are the most significant cognitive impairments in schizophrenia (SCZ). It has also been shown that WM performance is contingent on the cortex synchronization, a process that relies on brain inhibition. Repetitive Transcranial Magnetic Stimulation (rTMS) has been demonstrated as an effective treatment for patients with SCZ and has been shown to increase brain inhibition and improve cognitive performance. In this study the investigators intend to:
- evaluate rTMS as a treatment for WM deficits in SCZ
- evaluate rTMS as a method to increase WM performance in healthy individuals
- determine if improvements in WM performance are related to enhanced synchronization of brain networks
- determine whether genetic polymorphisms predict cortical function and treatment response
- evaluate the influence of rTMS treatment on brain structure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started May 2006
Longer than P75 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 14, 2011
CompletedFirst Posted
Study publicly available on registry
December 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedJune 11, 2013
June 1, 2013
6.5 years
December 14, 2011
June 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome measure will be the performance on the N-back working memory task.
Specifically, we will evaluate if rTMS results in changes to the number of correct answers, omissions and errors as well as reaction times.
4 weeks
Secondary Outcomes (2)
Increase in gamma band synchrony
4 weeks
Brain Imaging Changes
4 weeks
Study Arms (2)
Active rTMS
ACTIVE COMPARATORActive treatment will be delivered at an intensity that is 90% of the RMT. Stimulation will be delivered at either 20 Hz or 10 Hz, depending on the patients' tolerance to the stimulation, with 50 stimulation trains of 30 stimuli each (i.e., 1500 stimuli) and an intertrain interval of 30 sec. 25 trains will be applied to to the left or right hemisphere followed by the other hemisphere.
Sham rTMS
SHAM COMPARATORSham 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.
Interventions
Magnetic pulses to specified brain regions.
Eligibility Criteria
You may qualify if:
- Voluntary and competent to consent
- SCID-IV Diagnosis of Schizophrenia or Schizoaffective Disorder
- Between the ages of 18 and 85
- voluntary and competent to consent
- between the ages of 18-85
- considered a healthy individual free of psychopathology based on the Personality Assessment Inventory
- right-handed determined by the TMS screening and demographic form
- self-reported non-smoker
- do not have a self-reported concomitant major medical or neurologic illness
- if a woman of childbearing potential, must be on an effective means of birth control determined through completion of the TMS screening and demographic form.
You may not qualify if:
- Have a DSM-IV 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
- Have a first degree relative with a history of a seizure disorder
- Are pregnant
- Have any clinically significant EEG activity indicating an increased risk of seizure, as confirmed by a neurologist.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4, Canada
Related Publications (1)
Barr MS, Farzan F, Rajji TK, Voineskos AN, Blumberger DM, Arenovich T, Fitzgerald PB, Daskalakis ZJ. Can repetitive magnetic stimulation improve cognition in schizophrenia? Pilot data from a randomized controlled trial. Biol Psychiatry. 2013 Mar 15;73(6):510-7. doi: 10.1016/j.biopsych.2012.08.020. Epub 2012 Oct 3.
PMID: 23039931DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Z. Jeff Daskalakis, MD, PhD
CAMH
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
- Chair, Temerty Centre for Therapeutic Brain Intervention
Study Record Dates
First Submitted
December 14, 2011
First Posted
December 19, 2011
Study Start
May 1, 2006
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
June 11, 2013
Record last verified: 2013-06