tDCS for Schizophrenia

Overseen By Ariel Graff, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Must be taking: Antipsychotics

Must not be taking: Antiepileptics

Disqualifiers: Seizures, Substance dependence, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 10 days

32 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a novel study that seeks to explore the clinical and functional imaging effects of transcranial direct current stimulation (tDCS) on illness awareness or anosognosia in schizophrenia, arguably the most treatment-resistant manifestation of the disorder.

Research Team

Philip Gerretsen, MD, PhD

Principal Investigator

Centre for Addiction and Mental Health

Eligibility Criteria

This trial is for English-speaking adults over 18 with schizophrenia or schizoaffective disorder, who have a moderate-to-severe lack of illness awareness and are on stable medication. It excludes those taking antiepileptics, with acute suicidal thoughts, pregnant women, serious medical conditions including seizure history, recent substance dependence (except caffeine/nicotine), positive drug screen, MRI contraindications or low WRAT III score.

Inclusion Criteria

Having a DSM-IV diagnosis of schizophrenia or schizoaffective disorder

I am willing and able to agree to participate in this study.

Fluent in English

Exclusion Criteria

Positive urine drug screen for drugs of abuse

I am currently on medication for epilepsy.

Any contraindications to MRI (eg., metal implants that would preclude an MRI, claustrophobia)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dual hemisphere tDCS or sham stimulation daily for 10 days, with MRI scans and illness awareness assessments at baseline and after 10 days

10 days

Daily visits for 10 days

Follow-up

Participants are monitored for changes in illness awareness weekly for 4 weeks after tDCS

4 weeks

Weekly visits

Treatment Details

Interventions

• Active TDCS
• Sham TDCS

Trial Overview The study tests the effects of transcranial direct current stimulation (tDCS) on illness awareness in schizophrenia patients. Participants will receive either active tDCS or a sham treatment to compare outcomes using clinical assessments and functional imaging techniques.

Participant Groups

Group I: Sham TDCS Experimental Treatment 1 Intervention

Participants who are randomly assigned to this arm will receive dual hemisphere sham stimulation with electrodes placed on the parietal lobes (P3 and P4) daily for 10 days. Each participant will have two MRI scans and their degree of illness awareness assessed at baseline and after 10 days of tDCS. Illness awareness will be assessed weekly thereafter for 4 weeks.

Group II: Active TDCS Experimental Treatment 1 Intervention

Participants who are randomly assigned to this arm will receive dual hemisphere parietal (P3 cathodal, P4 anodal) stimulation daily for 10 days. Each participant will have two MRI scans and their degree of illness awareness assessed at baseline and after 10 days of tDCS. Illness awareness will be assessed weekly thereafter for 4 weeks.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+