Repetitive TMS & Cognitive Training in Adults With Schizophrenia (CrTMS)

February 1, 2023 updated by: Washington University School of Medicine

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: active rTMS with computerized cognitive training
Participants will receive 6 sessions of active rTMS followed by a computerized cognitive training session over 2 weeks.
Device: rTMS
Participants will receive either active or sham bilateral rTMS over the dorsolateral prefrontal cortex (DLPFC) for 12.5 min per side.
Other Names:
  • High frequency repetitive transcranial magnetic stimulation
Behavioral: Computerized cognitive training
All participants will receive computerized cognitive training for 40 min after each rTMS session.
Sham Comparator: sham rTMS with computerized cognitive training
Participants will receive 6 sessions of sham rTMS followed by a computerized cognitive training session over 2 weeks.
Behavioral: Computerized cognitive training
All participants will receive computerized cognitive training for 40 min after each rTMS session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences between groups on neuropsychological functioning
Time Frame: 2 weeks
Evaluate differences in neuropsychological functioning between active and sham rTMS groups using the Screen for Cognitive Impairment in Psychiatry (SCIP).
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences between groups on life skills
Time Frame: 2 weeks
Evaluate differences in daily functioning between active and sham rTMS groups using the Canadian Objective Assessment of Life Skills (COALS).
2 weeks
Differences between groups on disability
Time Frame: 2 weeks
Evaluate differences in daily functioning between active and sham rTMS groups using the WHO Disability Assessment Schedule (WHODAS).
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

January 30, 2024

Study Registration Dates

First Submitted

November 8, 2018

First Submitted That Met QC Criteria

November 12, 2018

First Posted (Actual)

November 15, 2018

Study Record Updates

Last Update Posted (Actual)

February 2, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201808164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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