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
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Other: Active TDCS Other: Sham TDCS||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|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|
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
- 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.
- 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.
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
|Contact: Philip Gerretsen, MD, PhD||416-535-8501 ext firstname.lastname@example.org|
|Contact: Ariel Graff, MD, PhD||416-535-8501 ext email@example.com|
|Centre for Addiction and Mental Health||Recruiting|
|Toronto, Ontario, Canada, M5S 2S1|
|Contact: Philip Gerretsen, MD, PhD 416-535-8501 ext 39426 firstname.lastname@example.org|
|Contact: Ariel Graff, MD, PhD 416-535-8501 ext 34834 email@example.com|
|Principal Investigator:||Philip Gerretsen, MD, PhD||Centre for Addiction and Mental Health|