Recruiting

tDCS & Virtual Rehabilitation

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT02951208

Conditions

Clinical High Risk for Psychosis

Eligibility Criteria

Sex: All

Age: 16 - 30

Healthy Volunteers: Not accepted

Interventions

Active tDCS

Active VR Motivation Training

Sham tDCS

Sham VR Motivation Training

Study Details

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.

Conditions

Clinical High Risk for Psychosis

Study ID

NCT02951208

Start date

Oct, 2016

Status verified date

May, 2020

Completion date

Sep, 2021

Anticipated

Primary completion date

Sep, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 30

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

22 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

sham comparator: 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.

Interventions

Active tDCS

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

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.

Sham tDCS

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

Sham VR Motivation Training

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

Primary outcome measure

  • Scale of Prodromal Symptoms - Negative Subscale (SOPS-Neg) [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

George Foussias, MD PhD FRCPC

416-535-8501george.foussias@camh.ca

Jessica D'Arcey

416-535-8501jessica.darcey@camh.ca

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M5T 1R8

Contacts

George Foussias, MD PhD FRCPC

416-535-8501george.foussias@camh.ca

Jessica D'Arcey

416-535-8501jessica.darcey@camh.ca

Principal Investigator:

George Foussias, MD PhD FRCPC

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

May 6, 2020

Last verified

May, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2020-05-06.