Clinical High Risk for PsychosisNCT02951208
tDCS Coupled With Virtual Rehabilitation for Negative Symptoms in At-Risk Youth
A study testing Active tDCS and Active VR Motivation Training in people with Clinical High Risk for Psychosis, run by Centre for Addiction and Mental Health at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Clinical High Risk for Psychosis
- What is being tested?
- Active tDCS and Active VR Motivation Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- between the ages of 16 and 30;
- meet CHR criteria for a psychosis risk syndrome determined by the Structured Interview for Prodromal Symptoms (SIPS);
- 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)
Who cannot join
- meet criteria for a current or lifetime psychotic disorder;
- have an IQ < 70;
- a history of seizures or clinically significant neurological disorder that may contribute to prodromal symptoms.
- have been involved in another treatment study in the past 4 weeks.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8
George Foussias, MD PhD FRCPC, 416-535-8501 ext. 34390, george.foussias@camh.ca
Jessica D'Arcey, 416-535-8501 ext. 32578, jessica.darcey@camh.ca
About this study
Official title: Transcranial Direct Current Stimulation Coupled With Virtual Rehabilitation for Negative Symptoms in At-Risk Youth
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.
Read the 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.
- Conditions
- Clinical High Risk for Psychosis
- Being tested
- Active tDCS, Active VR Motivation Training, Sham tDCS, Sham VR Motivation Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
Also called Active Transcranial Direct Current Stimulation
Active anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.
Active VR Motivation TrainingBehavioural
Active computerized treatment with a virtual reality-based motivation training program, administered for 60 minutes, three times per week for four weeks.
Sham tDCSDevice
Also called Sham Transcranial Direct Current Stimulation
Sham anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.
Sham VR Motivation TrainingBehavioural
Sham computerized training in a virtual reality-based environment, administered for 60 minutes, three times per week for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS + Active VR | Experimental | Active tDCS over the left DLPFC (30 minutes) combined with active VR motivation training (60 minutes), administered 3 times per week for 4 weeks. Receives: Device: Active tDCS; Behavioral: Active VR Motivation Training |
| Sham tDCS + Sham VR | Sham comparator | Sham tDCS over the left DLPFC (30 minutes) combined with sham VR motivation training (60 minutes), administered 3 times per week for 4 weeks. Receives: Device: Sham tDCS; Behavioral: Sham VR Motivation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale of Prodromal Symptoms - Negative Subscale (SOPS-Neg)
Measured: 8 weeks
Secondary outcomes (14)
Scale of Prodromal Symptoms - Positive Subscale (SOPS-Pos)
Measured: 8 weeks
Global Function: Role scale
Measured: 8 weeks
Global Function: Social scale
Measured: 8 weeks
Beck Scale for Suicidal Ideation (BSS)
Measured: 4 weeks
Calgary Depression Scale for Schizophrenia
Measured: 4 weeks
MATRICS Consensus Cognitive Battery (MCCB)
Measured: 4 weeks
Relationships Across Domains (RAD)
Measured: 4 weeks
Reading the Mind in the Eyes Task (RMET)
Measured: 4 weeks
The Awareness of Social Inferences Test (TASIT)
Measured: 4 weeks
Emotion Recognition - 40 (ER-40)
Measured: 4 weeks
Interpersonal Reactivity Index (IRI)
Measured: 4 weeks
Simulator Sickness Questionnaire (SSQ)
Measured: 4 weeks
Functional Brain Imaging
Change in regional brain activity measured with functional MRI
Measured: 4 weeks
Structural Brain Imaging
Changes in brain structure (e.g., white matter tract integrity) measure with structural MRI
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical High Risk for PsychosisStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Foussias, Centre for Addiction and Mental Health
- Investigators
- George Foussias, MD PhD FRCPC, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951208
- Sponsor's protocol ID
- 039-2016
- Status last verified
- May 2020
- First submitted
- 28 Oct 2016
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation Coupled With Virtual Rehabilitation for Negative Symptoms in At-Risk Youth
- ClinicalTrials.gov ID
- NCT02951208
- Acronym / sponsor ID
- 039-2016
- Conditions
- Clinical High Risk for Psychosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS + Active VR | Experimental | Device: Active tDCS, Behavioral: Active VR Motivation TrainingActive tDCS over the left DLPFC (30 minutes) combined with active VR motivation training (60 minutes), administered 3 times per week for 4 weeks. |
| Sham tDCS + Sham VR | Sham comparator | Device: Sham tDCS, Behavioral: Sham VR Motivation TrainingSham tDCS over the left DLPFC (30 minutes) combined with sham VR motivation training (60 minutes), administered 3 times per week for 4 weeks. |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- between the ages of 16 and 30;
- meet CHR criteria for a psychosis risk syndrome determined by the Structured Interview for Prodromal Symptoms (SIPS);
- 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)
Key exclusion criteria (4 listed)
- meet criteria for a current or lifetime psychotic disorder;
- have an IQ < 70;
- a history of seizures or clinically significant neurological disorder that may contribute to prodromal symptoms.
- have been involved in another treatment study in the past 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCSAlso: Active Transcranial Direct Current StimulationActive anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks. | Device | Active tDCS + Active VR |
| Active VR Motivation TrainingActive computerized treatment with a virtual reality-based motivation training program, administered for 60 minutes, three times per week for four weeks. | Behavioural | Active tDCS + Active VR |
| Sham tDCSAlso: Sham Transcranial Direct Current StimulationSham anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks. | Device | Sham tDCS + Sham VR |
| Sham VR Motivation TrainingSham computerized training in a virtual reality-based environment, administered for 60 minutes, three times per week for four weeks. | Behavioural | Sham tDCS + Sham VR |
Primary outcome
Scale of Prodromal Symptoms - Negative Subscale (SOPS-Neg)
Time frame: 8 weeks
14 secondary outcomes
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
Structural Brain Imaging
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Foussias, MD PhD FRCPC principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS and Active VR Motivation Training in people with Clinical High Risk for Psychosis, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact George Foussias, MD PhD FRCPC (416-535-8501 ext. 34390, george.foussias@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale of Prodromal Symptoms - Negative Subscale (SOPS-Neg) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.