tDCS Coupled With Virtual Rehabilitation for Negative Symptoms in At-Risk Youth
Primary Purpose
Clinical High Risk for Psychosis
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Active tDCS
Active VR Motivation Training
Sham tDCS
Sham VR Motivation Training
Sponsored by
About this trial
This is an interventional treatment trial for Clinical High Risk for Psychosis
Eligibility Criteria
Inclusion Criteria:
- between the ages of 16 and 30;
- meet CHR criteria for a psychosis risk syndrome determined by the Structured Interview for Prodromal Symptoms (SIPS);
- have a Scale of Prodromal Symptoms (SOPS) negative subscale (SOPS-Neg) score of > 11, with at least one negative symptom of at least moderate severity (i.e., ≥ 3)
Exclusion Criteria:
- meet criteria for a current or lifetime psychotic disorder;
- have an IQ < 70;
- a history of seizures or clinically significant neurological disorder that may contribute to prodromal symptoms.
- have been involved in another treatment study in the past 4 weeks.
Sites / Locations
- Centre for Addiction and Mental HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active tDCS + Active VR
Sham tDCS + Sham VR
Arm Description
Active tDCS over the left DLPFC (30 minutes) combined with active VR motivation training (60 minutes), administered 3 times per week for 4 weeks.
Sham tDCS over the left DLPFC (30 minutes) combined with sham VR motivation training (60 minutes), administered 3 times per week for 4 weeks.
Outcomes
Primary Outcome Measures
Scale of Prodromal Symptoms - Negative Subscale (SOPS-Neg)
Secondary Outcome Measures
Scale of Prodromal Symptoms - Positive Subscale (SOPS-Pos)
Global Function: Role scale
Global Function: Social scale
Beck Scale for Suicidal Ideation (BSS)
Calgary Depression Scale for Schizophrenia
MATRICS Consensus Cognitive Battery (MCCB)
Relationships Across Domains (RAD)
Reading the Mind in the Eyes Task (RMET)
The Awareness of Social Inferences Test (TASIT)
Emotion Recognition - 40 (ER-40)
Interpersonal Reactivity Index (IRI)
Simulator Sickness Questionnaire (SSQ)
Functional Brain Imaging
Change in regional brain activity measured with functional MRI
Structural Brain Imaging
Changes in brain structure (e.g., white matter tract integrity) measure with structural MRI
Full Information
NCT ID
NCT02951208
First Posted
October 28, 2016
Last Updated
May 5, 2020
Sponsor
Centre for Addiction and Mental Health
1. Study Identification
Unique Protocol Identification Number
NCT02951208
Brief Title
tDCS Coupled With Virtual Rehabilitation for Negative Symptoms in At-Risk Youth
Official Title
Transcranial Direct Current Stimulation Coupled With Virtual Rehabilitation for Negative Symptoms in At-Risk Youth
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (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
Negative symptoms, which include the loss of motivation, social withdrawal and reduced emotional expression are prominent in youth at clinical high risk (CHR) for psychosis. These negative symptoms lead to significant functional impairment and enduring disability in these youth. At present, there are no established treatments for negative symptoms. Recent evidence from independent studies, however, suggests two promising novel treatment approaches for negative symptoms, transcranial direct current stimulation (tDCS), and computerized remediation strategies. The primary aim of this study is to evaluate if tDCS combined with a virtual reality-based computerized remediation (VR) is effective for treating negative symptoms in CHR youth, thereby mitigating the enduring functional disability these symptoms cause.
Detailed Description
Negative symptoms, which include amotivation, social withdrawal and diminished emotional expression are prominent in youth at clinical high risk (CHR) for psychosis. Negative symptoms lead to significant functional impairment and enduring disability in these youth regardless of subsequent conversion to psychosis. At present, there are no established treatments for negative symptoms. Recent evidence from independent studies, however, suggests two promising novel treatment approaches for negative symptoms, transcranial direct current stimulation (tDCS), and computerized remediation strategies, both of which have revealed significant therapeutic effects on negative symptoms in schizophrenia (SZ). tDCS involves delivery of a low intensity continuous electrical field to the frontal cortex. tDCS is very safe and well tolerated, and is currently being investigated as a treatment for several psychiatric disorders. tDCS is also Health Canada approved for the treatment of major depressive disorder. The primary aim of this randomized controlled trial is to evaluate if tDCS combined with a virtual reality-based computerized remediation (VR), administered three times per week for four weeks, is effective for treating negative symptoms in CHR youth, thereby mitigating the enduring functional disability these symptoms cause.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical High Risk for Psychosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS + Active VR
Arm Type
Experimental
Arm Description
Active tDCS over the left DLPFC (30 minutes) combined with active VR motivation training (60 minutes), administered 3 times per week for 4 weeks.
Arm Title
Sham tDCS + Sham VR
Arm Type
Sham Comparator
Arm Description
Sham tDCS over the left DLPFC (30 minutes) combined with sham VR motivation training (60 minutes), administered 3 times per week for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Active tDCS
Other Intervention Name(s)
Active Transcranial Direct Current Stimulation
Intervention Description
Active anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.
Intervention Type
Behavioral
Intervention Name(s)
Active VR Motivation Training
Intervention Description
Active computerized treatment with a virtual reality-based motivation training program, administered for 60 minutes, three times per week for four weeks.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Other Intervention Name(s)
Sham Transcranial Direct Current Stimulation
Intervention Description
Sham anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.
Intervention Type
Behavioral
Intervention Name(s)
Sham VR Motivation Training
Intervention Description
Sham computerized training in a virtual reality-based environment, administered for 60 minutes, three times per week for four weeks.
Primary Outcome Measure Information:
Title
Scale of Prodromal Symptoms - Negative Subscale (SOPS-Neg)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Scale of Prodromal Symptoms - Positive Subscale (SOPS-Pos)
Time Frame
8 weeks
Title
Global Function: Role scale
Time Frame
8 weeks
Title
Global Function: Social scale
Time Frame
8 weeks
Title
Beck Scale for Suicidal Ideation (BSS)
Time Frame
4 weeks
Title
Calgary Depression Scale for Schizophrenia
Time Frame
4 weeks
Title
MATRICS Consensus Cognitive Battery (MCCB)
Time Frame
4 weeks
Title
Relationships Across Domains (RAD)
Time Frame
4 weeks
Title
Reading the Mind in the Eyes Task (RMET)
Time Frame
4 weeks
Title
The Awareness of Social Inferences Test (TASIT)
Time Frame
4 weeks
Title
Emotion Recognition - 40 (ER-40)
Time Frame
4 weeks
Title
Interpersonal Reactivity Index (IRI)
Time Frame
4 weeks
Title
Simulator Sickness Questionnaire (SSQ)
Time Frame
4 weeks
Title
Functional Brain Imaging
Description
Change in regional brain activity measured with functional MRI
Time Frame
4 weeks
Title
Structural Brain Imaging
Description
Changes in brain structure (e.g., white matter tract integrity) measure with structural MRI
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
between the ages of 16 and 30;
meet CHR criteria for a psychosis risk syndrome determined by the Structured Interview for Prodromal Symptoms (SIPS);
have a Scale of Prodromal Symptoms (SOPS) negative subscale (SOPS-Neg) score of > 11, with at least one negative symptom of at least moderate severity (i.e., ≥ 3)
Exclusion Criteria:
meet criteria for a current or lifetime psychotic disorder;
have an IQ < 70;
a history of seizures or clinically significant neurological disorder that may contribute to prodromal symptoms.
have been involved in another treatment study in the past 4 weeks.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
George Foussias, MD PhD FRCPC
Phone
416-535-8501
Ext
34390
Email
george.foussias@camh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica D'Arcey
Phone
416-535-8501
Ext
32578
Email
jessica.darcey@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Foussias, MD PhD FRCPC
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
M5T 1R8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Foussias, MD PhD FRCPC
Phone
416-535-8501
Ext
34390
Email
george.foussias@camh.ca
First Name & Middle Initial & Last Name & Degree
Jessica D'Arcey
Phone
416-535-8501
Ext
32578
Email
jessica.darcey@camh.ca
First Name & Middle Initial & Last Name & Degree
George Foussias, MD PhD FRCPC
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.camh.ca/en/research
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.
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tDCS Coupled With Virtual Rehabilitation for Negative Symptoms in At-Risk Youth
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