The Effects of tDCS on Illness Awareness in Schizophrenia

NCT ID: NCT02848885

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2025-05-13

Brief Summary

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.

Detailed Description

Transcranial DCS is a novel, non-invasive and non-convulsive technique for altering brain function. To our knowledge, no research has investigated the functional and behavioural effects of tDCS on anosognosia in schizophrenia. As such, we aim to improve impaired illness awareness in schizophrenia with tDCS by inhibiting left hemisphere regions (i.e. temporoparietooccipital cortex) shown by our group to be activated during illness denial.

Positive results will demonstrate that impaired illness awareness in schizophrenia involves a similar brain network to impaired illness awareness in patients with brain lesions and can be similarly modulated with non-invasive techniques, such as tDCS. If proven effective, this easy to administer, safe, non-invasive intervention would have the potential to alter individuals' attitude towards their illness and medication, leading ultimately to an improvement in individuals' capacity for illness recognition and treatment engagement, which would undoubtedly have a significant impact on the management of this devastating mental disorder.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Active TDCS

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.

Group Type: EXPERIMENTAL

Active TDCS

Intervention Type: OTHER

Participants will receive active tDCS stimulation.

Sham TDCS

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 Type: EXPERIMENTAL

Sham TDCS

Intervention Type: OTHER

Participants will receive sham tDCS stimulation

Interventions

Active TDCS

Participants will receive active tDCS stimulation.

Intervention Type: OTHER

Sham TDCS

Participants will receive sham tDCS stimulation

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Philip Gerretsen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip Gerretsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Countries

Canada

Related Links

http://www.camh.net/research

Description: The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.

Other Identifiers

043-2016

Identifier Type: -

Identifier Source: org_study_id