tDCS Coupled With Virtual Rehabilitation for Negative Symptoms in At-Risk Youth

Not Applicable

• Conditions: Clinical High Risk for Psychosis
• Interventions: Device: Sham tDCS; Device: Active tDCS; Behavioral: Active VR Motivation Training; Behavioral: Sham VR Motivation Training

• Registration Number: NCT02951208
• Lead Sponsor: Centre for Addiction and Mental Health

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-28
• Study First Submitted QC: 2016-10-28
• Study First Posted: 2016-11-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-05
• Last Update Posted: 2020-05-06
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. between the ages of 16 and 30;
2. meet CHR criteria for a psychosis risk syndrome determined by the Structured Interview for Prodromal Symptoms (SIPS);
3. 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

1. meet criteria for a current or lifetime psychotic disorder;
2. have an IQ < 70;
3. a history of seizures or clinically significant neurological disorder that may contribute to prodromal symptoms.
4. have been involved in another treatment study in the past 4 weeks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tDCS + Sham VR	Sham tDCS	Sham tDCS over the left DLPFC (30 minutes) combined with sham VR motivation training (60 minutes), administered 3 times per week for 4 weeks.
Active tDCS + Active VR	Active tDCS	Active tDCS over the left DLPFC (30 minutes) combined with active VR motivation training (60 minutes), administered 3 times per week for 4 weeks.
Active tDCS + Active VR	Active VR Motivation Training	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 + Sham VR	Sham VR Motivation Training	Sham tDCS over the left DLPFC (30 minutes) combined with sham VR motivation training (60 minutes), administered 3 times per week for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Scale of Prodromal Symptoms - Negative Subscale (SOPS-Neg)	8 weeks

Secondary Outcome Measures

Name	Time	Method
Scale of Prodromal Symptoms - Positive Subscale (SOPS-Pos)	8 weeks
Global Function: Role scale	8 weeks
Global Function: Social scale	8 weeks
Beck Scale for Suicidal Ideation (BSS)	4 weeks
Calgary Depression Scale for Schizophrenia	4 weeks
MATRICS Consensus Cognitive Battery (MCCB)	4 weeks
Relationships Across Domains (RAD)	4 weeks
Reading the Mind in the Eyes Task (RMET)	4 weeks
The Awareness of Social Inferences Test (TASIT)	4 weeks
Emotion Recognition - 40 (ER-40)	4 weeks
Interpersonal Reactivity Index (IRI)	4 weeks
Simulator Sickness Questionnaire (SSQ)	4 weeks
Functional Brain Imaging	4 weeks	Change in regional brain activity measured with functional MRI
Structural Brain Imaging	4 weeks	Changes in brain structure (e.g., white matter tract integrity) measure with structural MRI

Trial Locations

Locations (1)

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada