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

NCT02951208 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-05-06

No results posted yet for this study

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.

Conditions

  • Clinical High Risk for Psychosis

Interventions

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.

Sponsors & Collaborators

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • George Foussias, MD PhD FRCPC · Centre for Addiction and Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02951208 on ClinicalTrials.gov