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tDCS + Cognitive Remediation for Schizophrenia

N/A

Waitlist Available

Led By Michael W Best, PhD

Research Sponsored by University of Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Summary

This trialwill study whether combining Transcranial direct current stimulation (tDCS) with cognitive remediation can improve cognitive abilities in those with schizophrenia-spectrum disorders.

Who is the study for?

This trial is for adults aged 18-65 with schizophrenia or related psychotic disorders, who are not currently abusing drugs or alcohol. Participants must speak English, be able to use a computer, and not have any recent cognitive training. Pregnant individuals, those with seizure disorders, neurological diseases or damage, significant medical illnesses affecting brain function, or severe head injuries are excluded.

What is being tested?

The study tests if Transcranial direct current stimulation (tDCS) can boost the effectiveness of executive function training in improving cognitive abilities in people with schizophrenia-spectrum disorders. Half will receive real tDCS while the other half get a sham treatment; all participants will undergo cognitive remediation.

What are the potential side effects?

Potential side effects of tDCS may include mild tingling on the scalp, itching under the electrode site during stimulation, headache after sessions and fatigue. Serious risks like seizures are rare but possible especially in susceptible individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Specific Levels of Functioning (SLOF)

Secondary study objectives

Brief Core Schema Scale (BCSS)

Brief Psychiatric Rating Scale (BPRS)

Cambridge Neuropsychological Test Automated Battery (CANTAB)

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Actual tDCs + ETExperimental Treatment2 Interventions

Group II: Sham tDCs + ETPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial direct current stimulation

2012

Completed Phase 3

~650

Executive function training

2018

N/A

~50