tDCS and Executive Function Training for Schizophrenia

NCT05389345 | Withdrawn

• 1 other identifier: 41543
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Schizophrenia; Cognitive remediation; Transcranial direct current stimulation; tDCs; CR; cognitive rehabilitation; executive function training; ET

Outcome Measures

Primary Outcomes (1)

• Specific Levels of Functioning (SLOF)

  The SLOF scale is a measure of community functioning

  Change from baseline to 3-month follow-up

Secondary Outcomes (13)

• Cambridge Neuropsychological Test Automated Battery (CANTAB)

  baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up

• Reading subtest of the Wide Range Achievement Test (WRAT)

  baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up

• Questionnaire About the Process of Recovery (QPR)

  baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up

• Brief Psychiatric Rating Scale (BPRS)

  baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up

• Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

  baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up

Study Arms (2)

Actual tDCs + ET

EXPERIMENTAL

All interventions will involve 4 weeks of group intervention consisting of two 1-hour group sessions per week and additional practice between sessions. Half of study participants will be randomized to receive 30 minutes of transcranial direct current stimulation (tDCS) prior to beginning each ET session. ET session will begin immediately after tDCS.

Behavioral: Transcranial direct current stimulation; Behavioral: Executive function training

Sham tDCs + ET

SHAM COMPARATOR

All interventions will involve 4 weeks of group intervention consisting of two 1-hour group sessions per week and additional practice between sessions. Half of study participants will be randomized to receive 30 minutes of sham transcranial direct current stimulation (tDCS) prior to beginning each ET session. ET session will begin immediately after tDCS. During the sham tDCS, the procedures will be exactly the same as the real tDCS (e.g., application of electrodes), however, no stimulation will be provided when the device turned on.

Behavioral: Executive function training

Interventions

Transcranial direct current stimulation BEHAVIORAL

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.

Also known as: tDCS

Actual tDCs + ET

Executive function training BEHAVIORAL

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.

Also known as: ET, Cognitive remediation, CR

Actual tDCs + ET; Sham tDCs + ET

Eligibility Criteria

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

You may qualify if:

• those who meet the criteria of schizophrenia, schizoaffective disorder or any other psychotic disorder based on the DSM-V criteria
• years of age
• know how to use a computer
• are not abusing drugs or alcohol (criteria met for abuse in the last month)
• can read and speak English

You may not qualify if:

• anyone enrolled in a cognitive training program in the last 6 months
• anyone with a neurological disease or neurological damage, medical illnesses that can change neurocognitive function, medical history of head injury with loss of consciousness
• with a neurological disease or neurological damage, medical illnesses that can change neurocognitive function, medical history of head injury with loss of consciousness
• those with a seizure disorder
• those who are pregnant
• those with psychotic symptoms that in the opinion of the study psychiatrist, would impose risk of distress and/or decompensation of psychosis (e.g. delusion of influence through electricity)

Sponsors & Collaborators

• University of Toronto: lead
• Ontario Shores Centre for Mental Health Sciences: collaborator

Study Sites (1)

Ontario Shores Centre for Mental Health Sciences (Ontario Shores)

Whitby, Ontario, L1N 5S9, Canada

Location

Related Publications (29)

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MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Direct Current Stimulation; Cognitive Remediation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Behavior Therapy; Psychotherapy

Study Officials

• Michael W Best, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The randomization sequence will be pre-generated by the study coordinator who will then inform the treating clinician. The assessors obtaining outcome measure data will be blind to participants' assigned treatment groups. Participants will not be told which stimulation group they belong to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized to receive either actual transcranial direct current stimulation (tDCS) or sham tDCS prior to engaging in executive function training (ET). All participants will receive ET.

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 25, 2022
• Study Start: May 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)