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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2021-09-30

Brief Summary

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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.

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Detailed Description

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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

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Clinical High Risk for Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Active tDCS

Intervention Type DEVICE

Active anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.

Active VR Motivation Training

Intervention Type BEHAVIORAL

Active computerized treatment with a virtual reality-based motivation training program, administered for 60 minutes, three times per week for four weeks.

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.

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type DEVICE

Sham anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.

Sham VR Motivation Training

Intervention Type BEHAVIORAL

Sham computerized training in a virtual reality-based environment, administered for 60 minutes, three times per week for four weeks.

Interventions

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Active tDCS

Active anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Sham tDCS

Sham anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.

Intervention Type DEVICE

Sham VR Motivation Training

Sham computerized training in a virtual reality-based environment, administered for 60 minutes, three times per week for four weeks.

Intervention Type BEHAVIORAL

Other Intervention Names

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Active Transcranial Direct Current Stimulation Sham Transcranial Direct Current Stimulation

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No