The Effects of tDCS on Illness Awareness in Schizophrenia

NCT02848885 | Completed

• 1 other identifier: 043-2016
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Magnetic resonance imaging; Anosognosia; Electrical stimulation of the brain

Outcome Measures

Primary Outcomes (1)

• Illness awareness

  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.

  At baseline and weekly for 4 weeks after tDCS

Secondary Outcomes (1)

• Neural activity

  At baseline and post TDCS

Study Arms (2)

Active TDCS

EXPERIMENTAL

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.

Other: Active TDCS

Sham TDCS

EXPERIMENTAL

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.

Other: Sham TDCS

Interventions

Active TDCS OTHER

Participants will receive active tDCS stimulation.

Active TDCS

Sham TDCS OTHER

Participants will receive sham tDCS stimulation

Sham TDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Links

• 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.

MeSH Terms

Conditions

Schizophrenia; Agnosia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philip Gerretsen, MD, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 29, 2016
• Study Start: August 1, 2016
• Primary Completion: May 13, 2025
• Study Completion: May 13, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)