Repetitive TMS & Cognitive Training in Adults With Schizophrenia

NCT03741751 | Terminated Results FDA Device

• 1 other identifier: 201808164
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Cognitive Impairment

Keywords

cognition; schizophrenia; schizoaffective disorder

Outcome Measures

Primary Outcomes (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.

  2 weeks

Secondary Outcomes (1)

• Change in WHODAS Total Score From Baseline to 2 Weeks

  2 weeks

Study Arms (2)

active rTMS with computerized cognitive training

EXPERIMENTAL

Participants will receive 6 sessions of active rTMS followed by a computerized cognitive training session over 2 weeks.

Device: rTMS; Behavioral: Computerized cognitive training

sham rTMS with computerized cognitive training

SHAM COMPARATOR

Participants will receive 6 sessions of sham rTMS followed by a computerized cognitive training session over 2 weeks.

Behavioral: Computerized cognitive training

Interventions

rTMS DEVICE

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

Also known as: High frequency repetitive transcranial magnetic stimulation

active rTMS with computerized cognitive training

Computerized cognitive training BEHAVIORAL

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

active rTMS with computerized cognitive training; sham rTMS with computerized cognitive training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (13)

• 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.

  PMID: 20478878 BACKGROUND

• 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.

  PMID: 22581070 BACKGROUND

• 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.

  PMID: 28931460 BACKGROUND

• 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.

  PMID: 20521875 BACKGROUND

• 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.

  PMID: 21818354 BACKGROUND

• 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.

  PMID: 26593273 BACKGROUND

• 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.

  PMID: 19606086 BACKGROUND

• 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.

  PMID: 15531406 BACKGROUND

• 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.

  PMID: 18232722 BACKGROUND

• 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.

  PMID: 11495396 BACKGROUND

• 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.

  PMID: 23648193 BACKGROUND

• 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.

  PMID: 23200318 BACKGROUND

• 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.

  PMID: 20020047 BACKGROUND

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Cognitive Dysfunction; Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Limitations and Caveats

Recruitment and follow-up were discontinued early due to the COVID-19 pandemic, resulting in a small number of participants with complete outcome data (n=6). Given the limited sample size, results are descriptive and exploratory and should not be interpreted as definitive evidence of treatment efficacy.

Results Point of Contact

• Title: Rita Haddad
• Organization: Rita Haddad

haddad@wustl.edu

314-747-7851

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants will be masked to the TMS versus sham treatment. Sham treatment will be very similar to active TMS without the active magnetic stimulation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 15, 2018
• Study Start: January 15, 2019
• Primary Completion: December 31, 2023
• Study Completion: January 30, 2024
• Last Updated: March 10, 2026
• Results First Posted: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)