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The Effects of tDCS on Illness Awareness in Schizophrenia

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Active TDCS
Sham TDCS
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring Magnetic resonance imaging, Anosognosia, Electrical stimulation of the brain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Centre for Addiction and Mental HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Active TDCS

Sham TDCS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 15, 2016
Last Updated
September 14, 2023
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT02848885
Brief Title
The Effects of tDCS on Illness Awareness in Schizophrenia
Official Title
The Clinical and Functional Imaging Effects of Transcranial Direct Current Stimulation (tDCS) on Illness Awareness in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2016 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Magnetic resonance imaging, Anosognosia, Electrical stimulation of the brain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active TDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham TDCS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Active TDCS
Intervention Description
Participants will receive active tDCS stimulation.
Intervention Type
Other
Intervention Name(s)
Sham TDCS
Intervention Description
Participants will receive sham tDCS stimulation
Primary Outcome Measure Information:
Title
Illness awareness
Description
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.
Time Frame
At baseline and weekly for 4 weeks after tDCS
Secondary Outcome Measure Information:
Title
Neural activity
Description
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.
Time Frame
At baseline and post TDCS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Gerretsen, MD, PhD
Phone
416-535-8501
Ext
39426
Email
philip.gerretsen@camh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Ariel Graff, MD, PhD
Phone
416-535-8501
Ext
34834
Email
ariel.graff@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Gerretsen, MD, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Gerretsen, MD, PhD
Phone
416-535-8501
Ext
39426
Email
philip.gerretsen@camh.ca
First Name & Middle Initial & Last Name & Degree
Ariel Graff, MD, PhD
Phone
416-535-8501
Ext
34834
Email
ariel.graff@camh.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.camh.net/research
Description
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.

Learn more about this trial

The Effects of tDCS on Illness Awareness in Schizophrenia

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