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Completed

NCT Number: NCT02848885

The Effects of tDCS on Illness Awareness in Schizophrenia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female inpatients or outpatients ≥ 18 years of age
  • Having a DSM-IV diagnosis of schizophrenia or schizoaffective disorder
  • Voluntary and capable of consenting to participation in the research study
  • Fluent in English
  • Moderate-to-severe lack of illness awareness (≥3 on PANSS G12 Insight and Judgment item)
  • On a stable dose of antipsychotic and other concomitant medications, and unlikely to undergo changes in dose during the study

Exclusion criteria

  • 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
  • Acute suicidal and/or homicidal ideation
  • Formal thought disorder rating of over 2 on the (Scale for Assessment of Positive Symptoms) SAPS.
  • DSM-IV substance dependence (except caffeine and nicotine) within one month prior to entering the study
  • Pregnant women
  • Mild lack of insight to good illness awareness (<3 on PANSS G12 Insight and Judgment item).
  • Positive urine drug screen for drugs of abuse
  • Currently taking antiepileptics
  • Any contraindications to MRI (eg., metal implants that would preclude an MRI, claustrophobia)
  • Score < 32 on the Wide Range Achievement Test-III (WRAT III)

Treatment and study plan

Active TDCS

Other

Participants will receive active tDCS stimulation.

Sham tDCS

Other

Participants will receive sham tDCS stimulation

Primary outcomes

  1. Illness awareness

    Time frame: At baseline and weekly for 4 weeks after tDCS

    The 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 outcomes

  1. Neural activity

    Time frame: At baseline and post TDCS

    A 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.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2016
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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