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

Clinical High Risk for Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02951208
• Other study ID #: 039-2016
• Status: Recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: September 2021

Study information

• Verified date: May 2020
• Source: Centre for Addiction and Mental Health
• Contact: George Foussias, MD PhD FRCPC
• Phone: 416-535-8501
• Email: george.foussias[@]camh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clinical High Risk for Psychosis
• Psychotic Disorders

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scale of Prodromal Symptoms - Negative Subscale (SOPS-Neg)		8 weeks
Secondary	Scale of Prodromal Symptoms - Positive Subscale (SOPS-Pos)		8 weeks
Secondary	Global Function: Role scale		8 weeks
Secondary	Global Function: Social scale		8 weeks
Secondary	Beck Scale for Suicidal Ideation (BSS)		4 weeks
Secondary	Calgary Depression Scale for Schizophrenia		4 weeks
Secondary	MATRICS Consensus Cognitive Battery (MCCB)		4 weeks
Secondary	Relationships Across Domains (RAD)		4 weeks
Secondary	Reading the Mind in the Eyes Task (RMET)		4 weeks
Secondary	The Awareness of Social Inferences Test (TASIT)		4 weeks
Secondary	Emotion Recognition - 40 (ER-40)		4 weeks
Secondary	Interpersonal Reactivity Index (IRI)		4 weeks
Secondary	Simulator Sickness Questionnaire (SSQ)		4 weeks
Secondary	Functional Brain Imaging	Change in regional brain activity measured with functional MRI	4 weeks
Secondary	Structural Brain Imaging	Changes in brain structure (e.g., white matter tract integrity) measure with structural MRI	4 weeks

External 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.