Clinical trial NCT02951208: tDCS Coupled With Virtual Rehabilitation for Negative Symptoms in At-Risk Youth
Official title: Transcranial Direct Current Stimulation Coupled With Virtual Rehabilitation for Negative Symptoms in At-Risk Youth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clinical High Risk for Psychosis
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 22
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Scale of Prodromal Symptoms - Negative Subscale (SOPS-Neg)
timeFrame: 8 weeks
Secondary outcomes:
measure: Scale of Prodromal Symptoms - Positive Subscale (SOPS-Pos)
timeFrame: 8 weeks
measure: Global Function: Role scale
timeFrame: 8 weeks
measure: Global Function: Social scale
timeFrame: 8 weeks
measure: Beck Scale for Suicidal Ideation (BSS)
timeFrame: 4 weeks
measure: Calgary Depression Scale for Schizophrenia
timeFrame: 4 weeks
measure: MATRICS Consensus Cognitive Battery (MCCB)
timeFrame: 4 weeks
measure: Relationships Across Domains (RAD)
timeFrame: 4 weeks
measure: Reading the Mind in the Eyes Task (RMET)
timeFrame: 4 weeks
measure: The Awareness of Social Inferences Test (TASIT)
timeFrame: 4 weeks
measure: Emotion Recognition - 40 (ER-40)
timeFrame: 4 weeks
measure: Interpersonal Reactivity Index (IRI)
timeFrame: 4 weeks
measure: Simulator Sickness Questionnaire (SSQ)
timeFrame: 4 weeks
measure: Functional Brain Imaging
timeFrame: 4 weeks
measure: Structural Brain Imaging
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: George Foussias, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: