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tDCS for Schizophrenia

N/A

Recruiting

Led By Philip Gerretsen, MD, PhD

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

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

Must have

Moderate-to-severe lack of illness awareness (≥3 on PANSS G12 Insight and Judgment item)

Be older than 18 years old

Must not have

Currently taking antiepileptics

Serious unstable medical illness or any concomitant major medical or neurological illness, including a history of seizures or a first degree relative with a history of a seizure disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and post tdcs

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of electrical stimulation on the brains of people with schizophrenia who have difficulty recognizing their illness.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated here, common side effects of tDCS may include mild tingling, itching or discomfort at the electrode sites during stimulation; headache; fatigue; nausea; and insomnia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a moderate-to-severe difficulty recognizing my illness.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on medication for epilepsy.

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I do not have any serious illnesses or a family history of seizure disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and weekly for 4 weeks after tdcs

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and weekly for 4 weeks after tdcs

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and weekly for 4 weeks after tdcs for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Illness awareness

Secondary study objectives

Neural activity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sham TDCSExperimental Treatment1 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 TDCSExperimental Treatment1 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.

0 / 3Eligibility criteria met