Effects of brain stimulation on awareness of schizophrenia
The Clinical and Functional Imaging Effects of Transcranial Direct Current Stimulation (tDCS) on Illness Awareness in Schizophrenia
This study is testing if a type of brain stimulation can help people with schizophrenia better understand their illness and engage more in their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre for Addiction and Mental Health Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT02848885 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of transcranial direct current stimulation (tDCS) on improving illness awareness in individuals with schizophrenia, particularly focusing on those with anosognosia. The approach involves non-invasive brain stimulation targeting specific regions of the brain associated with illness denial. By assessing both clinical outcomes and functional imaging, the study aims to demonstrate that tDCS can enhance patients' recognition of their condition and improve treatment engagement. This novel intervention could provide a new avenue for addressing one of the most challenging aspects of schizophrenia management.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with schizophrenia or schizoaffective disorder who exhibit moderate-to-severe lack of illness awareness.
Not a fit: Patients with serious unstable medical conditions, acute suicidal ideation, or mild lack of insight may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve patients' awareness of their illness and enhance their engagement with treatment.
How similar studies have performed: While the use of tDCS in this context is novel, similar non-invasive techniques have shown promise in other neurological conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female inpatients or outpatients ≥ 18 years of age 2. Having a DSM-IV diagnosis of schizophrenia or schizoaffective disorder 3. Voluntary and capable of consenting to participation in the research study 4. Fluent in English 5. Moderate-to-severe lack of illness awareness (≥3 on PANSS G12 Insight and Judgment item) 6. On a stable dose of antipsychotic and other concomitant medications, and unlikely to undergo changes in dose during the study Exclusion Criteria: 1. 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 2. Acute suicidal and/or homicidal ideation 3. Formal thought disorder rating of over 2 on the (Scale for Assessment of Positive Symptoms) SAPS. 4. DSM-IV substance dependence (except caffeine and nicotine) within one month prior to entering the study 5. Pregnant women 6. Mild lack of insight to good illness awareness (\<3 on PANSS G12 Insight and Judgment item). 7. Positive urine drug screen for drugs of abuse 8. Currently taking antiepileptics 9. Any contraindications to MRI (eg., metal implants that would preclude an MRI, claustrophobia) 10. Score \< 32 on the Wide Range Achievement Test-III (WRAT III)
Where this trial is running
Toronto, Ontario
- Centre for Addiction and Mental Health — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Philip Gerretsen, MD, PhD — Centre for Addiction and Mental Health
- Study coordinator: Philip Gerretsen, MD, PhD
- Email: philip.gerretsen@camh.ca
- Phone: 416-535-8501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.