We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified October 2016 by George Foussias, Centre for Addiction and Mental Health
Sponsor:
ClinicalTrials.gov Identifier:
NCT02951208
First Posted: November 1, 2016
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
George Foussias, Centre for Addiction and Mental Health
  Purpose
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.

Condition Intervention
Clinical High Risk for Psychosis Device: Active tDCS Behavioral: Active VR Motivation Training Device: Sham tDCS Behavioral: Sham VR Motivation Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation Coupled With Virtual Rehabilitation for Negative Symptoms in At-Risk Youth

Resource links provided by NLM:


Further study details as provided by George Foussias, Centre for Addiction and Mental Health:

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

Secondary Outcome Measures:
  • Scale of Prodromal Symptoms - Positive Subscale (SOPS-Pos) [ Time Frame: 8 weeks ]
  • Global Function: Role scale [ Time Frame: 8 weeks ]
  • Global Function: Social scale [ Time Frame: 8 weeks ]
  • Beck Scale for Suicidal Ideation (BSS) [ Time Frame: 4 weeks ]
  • Calgary Depression Scale for Schizophrenia [ Time Frame: 4 weeks ]
  • MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: 4 weeks ]
  • Relationships Across Domains (RAD) [ Time Frame: 4 weeks ]
  • Reading the Mind in the Eyes Task (RMET) [ Time Frame: 4 weeks ]
  • The Awareness of Social Inferences Test (TASIT) [ Time Frame: 4 weeks ]
  • Emotion Recognition - 40 (ER-40) [ Time Frame: 4 weeks ]
  • Interpersonal Reactivity Index (IRI) [ Time Frame: 4 weeks ]
  • Simulator Sickness Questionnaire (SSQ) [ Time Frame: 4 weeks ]
  • Functional Brain Imaging [ Time Frame: 4 weeks ]
    Change in regional brain activity measured with functional MRI

  • Structural Brain Imaging [ Time Frame: 4 weeks ]
    Changes in brain structure (e.g., white matter tract integrity) measure with structural MRI


Estimated Enrollment: 22
Study Start Date: October 2016
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Active tDCS
Active anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.
Other Name: Active Transcranial Direct Current Stimulation
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.
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.
Device: Sham tDCS
Sham anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.
Other Name: Sham Transcranial Direct Current Stimulation
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951208


Contacts
Contact: George Foussias, MD PhD FRCPC 416-535-8501 ext 34390 george.foussias@camh.ca
Contact: Jessica D'Arcey 416-535-8501 ext 32578 jessica.darcey@camh.ca

Locations
Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M5T 1R8
Contact: George Foussias, MD PhD FRCPC    416-535-8501 ext 34390    george.foussias@camh.ca   
Contact: Jessica D'Arcey    416-535-8501 ext 32578    jessica.darcey@camh.ca   
Principal Investigator: George Foussias, MD PhD FRCPC         
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
Principal Investigator: George Foussias, MD PhD FRCPC Centre for Addiction and Mental Health
  More Information

Additional Information:
Responsible Party: George Foussias, Clinician Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT02951208     History of Changes
Other Study ID Numbers: 039-2016
First Submitted: October 28, 2016
First Posted: November 1, 2016
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No