tDCS and Executive Function Training for Schizophrenia

NCT05389345 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-07-30

No results posted yet for this study

Summary

Schizophrenia-spectrum disorders are the most persistent, debilitating, and economically burdensome mental illnesses worldwide. Cognitive remediation (CR) is a psychological intervention based on principles of learning and neuroplasticity to improve cognitive abilities. The investigators previously developed a novel CR intervention specifically targeting executive functions and aimed here to enhance its effect on functioning by combining it with Transcranial direct current stimulation (tDCs). The primary goal is to determine whether receiving tDCS prior to CR improves one's ability to engage in cognitive activities and enhance cognitive abilities. To do so, 40 participants will be recruited with schizophrenia-spectrum disorders from Ontario Shores inpatient units, half of whom will receive real tDCS and half will receive sham tDCS, whereas all will receive CR. This study will provide important information on whether the outcome of training executive function can be further enhanced with non-invasive brain stimulation.

Conditions

  • Schizophrenia
  • Schizophrenia Spectrum Disorder
  • Schizophrenia and Related Disorders

Interventions

BEHAVIORAL

Transcranial direct current stimulation

Participants will receive bilateral prefrontal anodal stimulation with cathode placed on the back of the upper neck. Transcranial direct current stimulation (tDCS) will be delivered by a research assistant under the supervision of a psychiatrist.

BEHAVIORAL

Executive function training

The Executive Training (ET) aspect of the study will be completed by all participants. ET sessions consist of 50% of the session practicing computerized cognitive training exercises, and 50% of the session developing cognitive strategies to use in the computerized exercises. Participants are encouraged to complete 40 minutes of computerized training per day, and complete strategy worksheets, on the unit or in the library at Ontario Shores between sessions. ET will be delivered virtually and group sessions will be conducted using the online platform Zoom. For any group sessions, a PHIPA and PIPEDA compliant license will be used. This means that participants will not be able to record their screen using Zoom or a third-party program. Dr. Best will also go through some rules during the first group Zoom session regarding the use of third-party equipment and the importance of confidentiality.

Sponsors & Collaborators

  • Ontario Shores Centre for Mental Health Sciences

    collaborator OTHER
  • University of Toronto

    lead OTHER

Principal Investigators

  • Michael W Best, PhD · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05389345 on ClinicalTrials.gov