Skip to content

The Effects of tDCS on Illness Awareness in Schizophrenia

The Clinical and Functional Imaging Effects of Transcranial Direct Current Stimulation (tDCS) on Illness Awareness in Schizophrenia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02848885
Enrollment
32
Registered
2016-07-29
Start date
2016-08-31
Completion date
2025-05-13
Last updated
2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Magnetic resonance imaging, Anosognosia, Electrical stimulation of the brain

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.

Interventions

OTHERActive TDCS

Participants will receive active tDCS stimulation.

OTHERSham TDCS

Participants will receive sham tDCS stimulation

Sponsors

Centre for Addiction and Mental Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Illness awarenessAt baseline and weekly for 4 weeks after tDCSThe primary aim of this study is to determine if dual hemisphere tDCS daily for 10 days will lead to an improvement in illness awareness versus a control condition (sham tDCS), as measured by changes in illness awareness scores post intervention (10 days post tDCS and weekly x 4 weeks post tDCS) in participants with schizophrenia.

Secondary

MeasureTime frameDescription
Neural activityAt baseline and post TDCSA secondary aim of this study is to assess changes in brain network activity (blood oxygen level dependent-BOLD) before and after tDCS while performing an illness awareness task during functional MRI.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026