SchizophreniaNCT01880255
rTMS for Working Memory Deficits in Schizophrenia
A study testing Repetitive Transcranial Magnetic Stimulation in people with Schizophrenia and Schizoaffective Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to 7 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Working Memory Deficits in Schizophrenia and Effects on Brain Structure
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.
Read the detailed 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Schizophrenia, Cognition, Working Memory
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Also called MagPro X100 Series (Medtronic A/S, Copenhagen, Denmark)
rTMS is a non-invasive procedure involving the use of magnetic fields to stimulate nerve cells.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
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)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startJun 2013
- Primary completion7 Jan 2019
- Study completion7 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Aristotle Voineskos, Centre for Addiction and Mental Health
- Investigators
- Aristotle Voineskos, MD, PHD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880255
- Sponsor's protocol ID
- 057/2013
- Status last verified
- Jul 2019
- First submitted
- 14 Jun 2013
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33551284
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Working Memory Deficits in Schizophrenia and Effects on Brain Structure
- ClinicalTrials.gov ID
- NCT01880255
- Acronym / sponsor ID
- 057/2013
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Schizophrenia, Cognition, Working Memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jun 2013
- Primary completion
- 7 Jan 2019 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 18 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Active comparator | Device: Repetitive Transcranial Magnetic StimulationActive 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 |
| Sham rTMS | Sham comparator | Device: Repetitive Transcranial Magnetic StimulationSham 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 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationAlso: MagPro X100 Series (Medtronic A/S, Copenhagen, Denmark)rTMS is a non-invasive procedure involving the use of magnetic fields to stimulate nerve cells. | Device | Active rTMS, Sham rTMS |
Primary outcome
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.
1 secondary outcome
Brain Imaging Changes
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Derived from this study: PubMed 33551284Voineskos 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.
- 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 CentreLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
RecruitingPhase 1
A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
Schizophrenia
Recruiting
A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia
Schizophrenia, Antipsychotic Induced Weight Gain
Recruiting
Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study
Schizophrenia, Cerebellar Function
Recruiting
tACS for Working Memory in Schizophrenia
Schizophrenia, Working Memory
Recruiting
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 3
Schizophrenia / Schizoaffective Disorder, SCHIZOPHRENIA 1 (Disorder)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aristotle Voineskos, MD, PHD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Schizophrenia and Schizoaffective Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance on the N-back working memory task (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01880255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.