rTMS for Working Memory Deficits in Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2019-01-07

Brief Summary

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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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Detailed Description

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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.

Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active rTMS

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

Group Type ACTIVE_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

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

Sham rTMS

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

Group Type SHAM_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

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

Interventions

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Repetitive Transcranial Magnetic Stimulation

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

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No