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

Transcranial Direct Current Stimulation Coupled With Virtual Rehabilitation for Negative Symptoms in At-Risk Youth

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.

Study Overview

• Status: Unknown
• Conditions: Clinical High Risk for Psychosis
• Intervention / Treatment: Device: Active tDCS; Behavioral: Active VR Motivation Training; Device: Sham tDCS; Behavioral: Sham VR Motivation Training

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 Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: George Foussias, MD PhD FRCPC; Phone Number: 34390 416-535-8501; Email: george.foussias@camh.ca
• Study Contact Backup: Name: Jessica D'Arcey; Phone Number: 32578 416-535-8501; Email: jessica.darcey@camh.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 1R8
      • Recruiting
      • Centre for Addiction and Mental Health
      • Contact: George Foussias, MD PhD FRCPC; Phone Number: 34390 416-535-8501; Email: george.foussias@camh.ca
      • Contact: Jessica D'Arcey; Phone Number: 32578 416-535-8501; Email: jessica.darcey@camh.ca
      • Principal Investigator: George Foussias, MD PhD FRCPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active tDCS + Active VR; Active tDCS over the left DLPFC (30 minutes) combined with active VR motivation training (60 minutes), administered 3 times per week for 4 weeks.	Device: Active tDCS; Active anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.; Other Names: Active Transcranial Direct Current Stimulation; Behavioral: Active VR Motivation Training; Active computerized treatment with a virtual reality-based motivation training program, administered for 60 minutes, three times per week for four weeks.
Sham Comparator: Sham tDCS + Sham VR; Sham tDCS over the left DLPFC (30 minutes) combined with sham VR motivation training (60 minutes), administered 3 times per week for 4 weeks.	Device: Sham tDCS; Sham anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.; Other Names: Sham Transcranial Direct Current Stimulation; Behavioral: Sham VR Motivation Training; Sham computerized training in a virtual reality-based environment, administered for 60 minutes, three times per week for four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Scale of Prodromal Symptoms - Negative Subscale (SOPS-Neg)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change in regional brain activity measured with functional MRI	4 weeks
Structural Brain Imaging	Changes in brain structure (e.g., white matter tract integrity) measure with structural MRI	4 weeks

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Investigators: Principal Investigator: George Foussias, MD PhD FRCPC, Centre for Addiction and Mental Health

Publications and helpful links

Helpful Links

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: October 28, 2016
• First Submitted That Met QC Criteria: October 28, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders
• Other Study ID Numbers: 039-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No