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The Effects of tDCS on Illness Awareness in Schizophrenia

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ClinicalTrials.gov Identifier: NCT02848885
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Philip Gerretsen, Centre for Addiction and Mental Health

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Other: Active TDCS Other: Sham TDCS Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Clinical and Functional Imaging Effects of Transcranial Direct Current Stimulation (tDCS) on Illness Awareness in Schizophrenia
Study Start Date : August 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Active TDCS
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
Participants will receive active tDCS stimulation.

Experimental: Sham TDCS
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
Participants will receive sham tDCS stimulation




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848885


Contacts
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Contact: Philip Gerretsen, MD, PhD 416-535-8501 ext 39426 philip.gerretsen@camh.ca
Contact: Ariel Graff, MD, PhD 416-535-8501 ext 34834 ariel.graff@camh.ca

Locations
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Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M5S 2S1
Contact: Philip Gerretsen, MD, PhD    416-535-8501 ext 39426    philip.gerretsen@camh.ca   
Contact: Ariel Graff, MD, PhD    416-535-8501 ext 34834    ariel.graff@camh.ca   
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: Philip Gerretsen, MD, PhD Centre for Addiction and Mental Health

Additional Information:
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Responsible Party: Philip Gerretsen, Principal Investigator, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT02848885     History of Changes
Other Study ID Numbers: 043-2016
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Philip Gerretsen, Centre for Addiction and Mental Health:
Magnetic resonance imaging
Anosognosia
Electrical stimulation of the brain
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders