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Schizophrenia Spectrum and Other Psychotic DisordersCrTMSNCT03741751

Repetitive TMS & Cognitive Training in Adults With Schizophrenia

A study testing rTMS and Computerized cognitive training in people with Schizophrenia Spectrum and Other Psychotic Disorders and Cognitive Impairment, run by Washington University School of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The proposed project aims to establish the feasibility and tolerability of delivering repetitive transcranial magnetic stimulant (rTMS) combined with computerized cognitive training in patients with Schizophrenia or Schizoaffective Disorder and cognitive difficulties. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
rTMS and Computerized cognitive training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteUnited States
Study dates
15 Jan 2019to 30 Jan 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-65
  • Diagnosis of schizophrenia or schizoaffective disorder
  • Psychotic symptoms are stable

Who cannot join

  • Active substance use
  • History of seizures or seizure disorder
  • Active psychosis or recent psychiatric hospitalization
  • Use of medications that could impair cognitive functioning

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Repetitive Transcranial Magnetic Stimulation and Cognitive Training for Treatment of Cognitive Problems in Adults With Schizophrenia: A Pilot Randomized Trial

The proposed project aims to establish the feasibility and tolerability of delivering repetitive transcranial magnetic stimulant (rTMS) combined with computerized cognitive training in patients with Schizophrenia or Schizoaffective Disorder and cognitive difficulties.

The investigators will conduct a 2 week randomized controlled trial study evaluating computerized cognitive training combined with either active or sham rTMS on cognitive and functional outcomes in adults with Schizophrenia or Schizoaffective Disorder.

Read the detailed description

Schizophrenia affects approximately 1.1% of U.S adults per year and is among the most disabling psychiatric illnesses, due primarily to poor functioning related to cognitive dysfunction. Negative (e.g. flattened affect, limited speech output, lack of motivation) and cognitive symptoms (e.g. poor executive functioning, attention and working memory) are by far the leading cause of social, occupational and educational disability and functional impairment in patients with schizophrenia. Since the advent of antipsychotic medications, Schizophrenia treatment has improved significantly with respect to positive symptom control. However, there are limited resources for improving cognitive symptoms in Schizophrenia, which remain disabling for most with the diagnosis. Cognitive remediation and cognitive training programs have shown promise in improving these symptoms. Specifically, adults with Schizophrenia show significant improvements in cognition after participating in 2 weeks of computer based cognitive training. Functional capacity has also been shown to improve with longer periods of computer-based cognitive training. However, the effects of cognitive training alone may be most effective in the short-term. Longer term effectiveness of cognitive training has yet to be shown.

There has been emergent interest in using neuromodulation for treatment of cognitive decline in people with various illnesses including children with ADHD, adults with schizophrenia and older adults with late life depression. Specifically, high frequency (20Hz) rTMS applied to the dorsolateral prefrontal cortex (DLPFC) bilaterally has been shown to improve working memory in patients with schizophrenia. By improving neuroplasticity and working memory, rTMS could significantly improve effects of cognitive training in patients with schizophrenia. Combination cognitive training and rTMS treatment has been used in patients with depression with promising results. Previously, the implementation of cognitive training programs in clinical settings was challenged by the intensity of required patient engagement. However, our group and others have applied computerized training programming that is accessible remotely, improving accessibility and engagement. Thus, computerized training offers a feasible and scalable combination with neuromodulation treatment. Here, we propose to test rTMS, in combination with a computerized cognitive training program, to remediate cognitive dysfunction in Schizophrenia and Schizoaffective Disorder in a pilot randomized clinical trial.

Aim: Conduct a randomized pilot and feasibility study of active versus sham rTMS combined with computerized cognitive training program in adults with Schizophrenia or Schizophreniform Disorders, comparing neurocognitive and functional outcomes between groups.

1a) the investigators hypothesize favorable differences between groups in acute improvement on neuropsychological executive functioning, as measured by the Screen for Cognitive Impairment in Psychiatry (SCIP).

1b) The investigators hypothesize favorable differences between groups in daily functioning as measured by the Canadian Objective Assessment of Life Skills (COALS) and the WHO Disability Assessment Schedule (WHODAS) in participants receiving CrTMS compared to controls.

Being tested
rTMS, Computerized cognitive training
Keywords
cognition, schizophrenia, schizoaffective disorder
Medical subject headings
Schizophrenia Spectrum and Other Psychotic Disorders, Cognitive Dysfunction, Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rTMSDevice

    Also called High frequency repetitive transcranial magnetic stimulation

    Participants will receive either active or sham bilateral rTMS over the dorsolateral prefrontal cortex (DLPFC) for 12.5 min per side.

  • Computerized cognitive trainingBehavioural

    All participants will receive computerized cognitive training for 40 min after each rTMS session.

Study groups in NCT03741751
Study groupRoleWhat they receive
active rTMS with computerized cognitive trainingExperimentalParticipants will receive 6 sessions of active rTMS followed by a computerized cognitive training session over 2 weeks.
Receives: Device: rTMS; Behavioral: Computerized cognitive training
sham rTMS with computerized cognitive trainingSham comparatorParticipants will receive 6 sessions of sham rTMS followed by a computerized cognitive training session over 2 weeks.
Receives: Behavioral: Computerized cognitive training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in Groups on Neuropsychological Testing

    Evaluate differences in neuropsychological functioning between active and sham rTMS groups using the Screen for Cognitive Impairment in Psychiatry (SCIP). Scores are reported as Z-scores standardized to age-adjusted normative data. A Z-score of 0 represents the population mean, and each unit reflects one standard deviation from that mean. Higher Z-scores indicate better cognitive performance. Scores are interpreted relative to normative expectations rather than a diagnostic threshold. Change scores represent the value at 2 weeks minus the baseline value.

    Measured: 2 weeks

Secondary outcomes (1)
  1. Change in WHODAS Total Score From Baseline to 2 Weeks

    Disability was measured using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), a standardized instrument assessing functional impairment across multiple domains of daily living. Total scores range from 0 to 100, with higher scores indicating greater disability. Change scores were calculated as the value at 2 weeks minus the baseline value.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2018
  2. Study start15 Jan 2019
  3. Primary completion31 Dec 2023
  4. Study completion30 Jan 2024

Why it stopped: staff availability

Resources

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
Model description
randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03741751
Sponsor's protocol ID
201808164
Acronym
CrTMS
Status last verified
Mar 2026
First submitted
8 Nov 2018
Last updated
10 Mar 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Bowie CR, Depp C, McGrath JA, Wolyniec P, Mausbach BT, Thornquist MH, Luke J, Patterson TL, Harvey PD, Pulver AE. Prediction of real-world functional disability in chronic mental disorders: a comparison of schizophrenia and bipolar disorder. Am J Psychiatry. 2010 Sep;167(9):1116-24. doi: 10.1176/appi.ajp.2010.09101406. Epub 2010 May 17.

    PubMed 20478878
  • Bowie CR, McGurk SR, Mausbach B, Patterson TL, Harvey PD. Combined cognitive remediation and functional skills training for schizophrenia: effects on cognition, functional competence, and real-world behavior. Am J Psychiatry. 2012 Jul;169(7):710-8. doi: 10.1176/appi.ajp.2012.11091337.

    PubMed 22581070
  • Best MW, Gale D, Tran T, Haque MK, Bowie CR. Brief executive function training for individuals with severe mental illness: Effects on EEG synchronization and executive functioning. Schizophr Res. 2019 Jan;203:32-40. doi: 10.1016/j.schres.2017.08.052. Epub 2017 Sep 19.

    PubMed 28931460
  • Bloch Y, Harel EV, Aviram S, Govezensky J, Ratzoni G, Levkovitz Y. Positive effects of repetitive transcranial magnetic stimulation on attention in ADHD Subjects: a randomized controlled pilot study. World J Biol Psychiatry. 2010 Aug;11(5):755-8. doi: 10.3109/15622975.2010.484466.

    PubMed 20521875
  • Barr MS, Farzan F, Arenovich T, Chen R, Fitzgerald PB, Daskalakis ZJ. The effect of repetitive transcranial magnetic stimulation on gamma oscillatory activity in schizophrenia. PLoS One. 2011;6(7):e22627. doi: 10.1371/journal.pone.0022627. Epub 2011 Jul 27.

    PubMed 21818354
  • Cheng CM, Juan CH, Chen MH, Chang CF, Lu HJ, Su TP, Lee YC, Li CT. Different forms of prefrontal theta burst stimulation for executive function of medication- resistant depression: Evidence from a randomized sham-controlled study. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Apr 3;66:35-40. doi: 10.1016/j.pnpbp.2015.11.009. Epub 2015 Nov 22.

    PubMed 26593273
  • Barr MS, Farzan F, Rusjan PM, Chen R, Fitzgerald PB, Daskalakis ZJ. Potentiation of gamma oscillatory activity through repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex. Neuropsychopharmacology. 2009 Oct;34(11):2359-67. doi: 10.1038/npp.2009.79. Epub 2009 Jul 15.

    PubMed 19606086
  • Green MF, Kern RS, Heaton RK. Longitudinal studies of cognition and functional outcome in schizophrenia: implications for MATRICS. Schizophr Res. 2004 Dec 15;72(1):41-51. doi: 10.1016/j.schres.2004.09.009.

    PubMed 15531406
  • Janicak PG, O'Reardon JP, Sampson SM, Husain MM, Lisanby SH, Rado JT, Heart KL, Demitrack MA. Transcranial magnetic stimulation in the treatment of major depressive disorder: a comprehensive summary of safety experience from acute exposure, extended exposure, and during reintroduction treatment. J Clin Psychiatry. 2008 Feb;69(2):222-32. doi: 10.4088/jcp.v69n0208.

    PubMed 18232722
  • Manes F, Jorge R, Morcuende M, Yamada T, Paradiso S, Robinson RG. A controlled study of repetitive transcranial magnetic stimulation as a treatment of depression in the elderly. Int Psychogeriatr. 2001 Jun;13(2):225-31. doi: 10.1017/s1041610201007608.

    PubMed 11495396
  • Gomez-Benito J, Guilera G, Pino O, Rojo E, Tabares-Seisdedos R, Safont G, Martinez-Aran A, Franco M, Cuesta MJ, Crespo-Facorro B, Bernardo M, Vieta E, Purdon SE, Mesa F, Rejas J; Spanish Working Group in Cognitive Function. The screen for cognitive impairment in psychiatry: diagnostic-specific standardization in psychiatric ill patients. BMC Psychiatry. 2013 May 6;13:127. doi: 10.1186/1471-244X-13-127.

    PubMed 23648193
  • McDermid Vaz SA, Heinrichs RW, Miles AA, Ammari N, Archie S, Muharib E, Goldberg JO. The Canadian Objective Assessment of Life Skills (COALS): a new measure of functional competence in schizophrenia. Psychiatry Res. 2013 Apr 30;206(2-3):302-6. doi: 10.1016/j.psychres.2012.10.020. Epub 2012 Nov 27.

    PubMed 23200318
  • Andrews G, Kemp A, Sunderland M, Von Korff M, Ustun TB. Normative data for the 12 item WHO Disability Assessment Schedule 2.0. PLoS One. 2009 Dec 17;4(12):e8343. doi: 10.1371/journal.pone.0008343.

    PubMed 20020047

Questions about this trial

What is this clinical trial studying?

A study testing rTMS and Computerized cognitive training in people with Schizophrenia Spectrum and Other Psychotic Disorders and Cognitive Impairment, run by Washington University School of Medicine at 1 site in United States.

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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 10 Mar 2026. 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 United States. 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?

Yes. Results are posted in the registry (first posted 10 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Difference in Groups on Neuropsychological Testing (time frame: 2 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 NCT03741751, which also lists 13 linked publications.

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 10 Mar 2026.

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