The Effects of tDCS on Illness Awareness in Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02848885
• Other study ID #: 043-2016
• Status: Recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Centre for Addiction and Mental Health
• Contact: Philip Gerretsen, MD, PhD
• Phone: 416-535-8501
• Email: philip.gerretsen[@]camh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• Active TDCS
Participants will receive active tDCS stimulation.
• Sham TDCS
Participants will receive sham tDCS stimulation

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Neural activity	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.	At baseline and post TDCS

External 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.