NCT02951208

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 16 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clinical High Risk for Psychosis

Interventions

Type	Name	Description
DEVICE	Active tDCS	Active anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.
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.
DEVICE	Sham tDCS	Sham anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.
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.

Timeline

• Start date: 2016-10-01
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2016-11-01
• Last updated: 2020-05-06

Locations

1 site across 1 country: Canada