Behaviors and Mental DisordersNSOCOGNCT03213600
Neurostimulation-enhanced Behavioral Remediation of Social Cognition in Schizophrenia
A study testing transcranial Direct Current Stimulation tDCS in people with Behaviors and Mental Disorders, run by Hôpital le Vinatier at 1 site in France.
Trial summary
Social cognition concerns the understanding of how people think about others and how that, in turn, influences our behavior, feelings, and social interactions. schizophrenia social-cognitive impairment is profound (effect size D>1.2), medication resistant and critically limits functional well-being . Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Behaviors and Mental Disorders
- What is being tested?
- transcranial Direct Current Stimulation tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2018to 31 Dec 2019
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- be between 18 and 45-years-old
- have normal hearing assessed by the Five-minute hearing test
- have French as a first language
- be able to provide written informed consent
- be right handed as measured by the Edinburgh handedness scale
- covered by, or having the right to Social Security
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- informed consent signed
- patients with diagnosis of schizoprenia or schizoaffective disorder-depressive type as determined by the SCID Diagnostic Interview for DSM-V and administered by a clinician
- clinically stable and on a stable medication regiment for the past 3 months
Who cannot join
- significant medical or neurological illness or history of fetal alcohol exposure that may increase risks of the study, significantly affect brain function, or impede participation
- substance dependence (except nicotine) or abuse not in remission within the past six months or recent use presenting the possibility of acute intoxication or withdrawal
- a history of any Axis I psychiatric disorder except those required in the inclusion criteria, any history of pervasive developmental disorder or mental retardation
- for Visit 3: If participating in tCDS Contraindications for tDCS (pacemaker or brain stimulator) and/or MRI (neurologic stimulator, pacemaker, cardiac defibrillator, cardiac prosthesis, vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid derivation, metallic splinters in the eyes)
- patients under curatorship/guardianship and whose clinical condition requires inpatient procedure under constraint
- healthy controls must not be currently using psychoactive médications or have a first-degree relative with a psychotic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Social cognition concerns the understanding of how people think about others and how that, in turn, influences our behavior, feelings, and social interactions. schizophrenia social-cognitive impairment is profound (effect size D>1.2), medication resistant and critically limits functional well-being . Social cognition involves complex patterns of coordinated activity within numerous cortical and subcortical networks, making it a difficult target for clinical neuroscience investigation. Yet, prior research demonstrates that sensory-perceptual dysfunction in schizophrenia can upwardly generalize into higher-order social-cognitive impairment making perception a tractable and fruitful approach for studying social cognition in schizophrenia. Here, the investigators explore how distortions in perception of temporal coincidence can contribute to the aberrant inferences of physical causation and social agency.
Read the detailed description
Social cognitive deficits in these patients are robust and hinder their ability to maintain gainful employment as well as forge and sustain meaningful social relationships. Current antipsychotic medications are largely ineffective in treating these symptoms. The proposed protocol aims at utilizing Noninvasive Brain Stimulation (NIBS) and cognitive behavioral training to enhance core perceptual impairment in marking time that may contribute to both social and nonsocial cognitive dysfunction in schizophrenia.
Cognitive behavioral training along the line investigators propose has no reported adverse effects.The transdirect current stimulation (tDCS) is a very safe method with encouraging results in previous works in which no severe adverse events where found. There are a few minor side effects including skin irritation, a phosphene at the start of stimulation, nausea, headache, dizziness, and itching under the electrode. A recent study of over 500 subjects using the currently accepted protocol reported only a slight skin irritation and a phosphene as side effects. Patients can benefit from a significant improvement of invalidant symptoms but also of their quality of life. To ensure safety, patients will be accompanied throughout the protocol by professionals trained in the management of their disease. Besides the protocol procedure, patients will be supported, in all centers, according to the international recommendations in terms of safety and practice. Patients receiving placebo procedure after randomization will pursue pharmacological treatment and usual health care.
- Conditions
- Behaviors and Mental Disorders
- Being tested
- transcranial Direct Current Stimulation tDCS
- Medical subject headings
- Behavior, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial Direct Current Stimulation tDCSDevice
75 participants will receive 20 minutes of active tDCS (1,5mA, 20 minutes stimulation over frontal (F3/F4) electrodes ); A group of 75 participants will receive 1,5mA 20 minutes of stimulation over parietal (CP3 CP4) electrodes. During this stimulation session and we will also measure your ability to perceive visual and auditory objects presented by a computer, while recording your brain activity using electroencephalography or EEG (a technique using electrodes that measures the electrical activity of your brain)
| Study group | Role | What they receive |
|---|---|---|
| transcranial Direct Current Stimulation ( tDCS ) | Active comparator | Intensity : 1,5mA Duration : 20 minutes stimulation over frontal (F3/F4) electrodes Receives: Device: transcranial Direct Current Stimulation tDCS |
| transcranial Direct Current Stimulation ( tDCS) | Sham comparator | Intensity : 1,5mA Duration : 20 minutes stimulation over parietal(CP3 CP4) electrodes Receives: Device: transcranial Direct Current Stimulation tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Causation Task - testing time based causal judgments
Primary metric: threshold defined as the smallest time difference (in 16.7ms increments) at which subject judge ball movement "B" to be caused by the impact of ball "A" 75% of the time.
Measured: 3 months
Triangle Task - measuring the extent to which temporal coincidence is used to infer causality in a social situation
Primary metric: threshold of tolerated relational time delay (levels in 16.7ms increments) between interacting visual figures (i.e triangles), under which participants reliably (at 75%) perceive social agency or social interactions.
Measured: 3 months
Secondary outcomes (3)
EEG Task 1, Time visual oddball task - for measuring electrophysiological markers of active temporal (time) deviance detection
Primary metric: Mismatch negativity in the event related potentials of electrodes over the visual cortex with typical latency of 150-250ms after the onset of the deviant stimuli
Measured: 3 months
EEG Task 2, Covert visual simultaneity task - an exploratory task designed to model the visual Simultaneity behavioral task
Primary metric: Dependent measure: decibel change in Alpha and Beta power across bellow- threshold and above- threshold conditions
Measured: 3 months
Resting state oscillatory structure
Primary metric: Dependent measure: decibel change in Alpha and Beta power during rest
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Nov 2018 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Why it stopped: One of the investigators went abroad
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behaviors and Mental DisordersStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will enroll 150 subjects comprising three population groups SZ, At Risk and HS.) Immediately after inclusion, participants will be randomized into 2 equal groups via random generation of two binary integer's reflecting tDCS-treatment condition or the tDCS control (sham) resulting in random allocation into one of 2 study arms. This randomization will be stratified per population group to insure that both conditions are equally reflected across all three groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- POULET EMMANUEL, MD - PhD, Principal investigator, CH LE VINATIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213600
- Sponsor's protocol ID
- 2017-A01042-51
- Acronym
- NSOCOG
- Status last verified
- Apr 2019
- First submitted
- 7 Jul 2017
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurostimulation-enhanced Behavioral Remediation of Social Cognition in Schizophrenia
- ClinicalTrials.gov ID
- NCT03213600
- Acronym / sponsor ID
- NSOCOG / 2017-A01042-51
- Conditions
- Behaviors and Mental Disorders
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: One of the investigators went abroad
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 11 Jul 2017 (actual)
- 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.
Social cognition concerns the understanding of how people think about others and how that, in turn, influences our behavior, feelings, and social interactions. schizophrenia social-cognitive impairment is profound (effect size D>1.2), medication resistant and critically limits functional well-being . Social cognition involves complex patterns of coordinated activity within numerous cortical and subcortical networks, making it a difficult target for clinical neuroscience investigation. Yet, prior research demonstrates that sensory-perceptual dysfunction in schizophrenia can upwardly generalize into higher-order social-cognitive impairment making perception a tractable and fruitful approach for studying social cognition in schizophrenia. Here, the investigators explore how distortions in perception of temporal coincidence can contribute to the aberrant inferences of physical causation and social agency.
Detailed description
Social cognitive deficits in these patients are robust and hinder their ability to maintain gainful employment as well as forge and sustain meaningful social relationships. Current antipsychotic medications are largely ineffective in treating these symptoms. The proposed protocol aims at utilizing Noninvasive Brain Stimulation (NIBS) and cognitive behavioral training to enhance core perceptual impairment in marking time that may contribute to both social and nonsocial cognitive dysfunction in schizophrenia.
Cognitive behavioral training along the line investigators propose has no reported adverse effects.The transdirect current stimulation (tDCS) is a very safe method with encouraging results in previous works in which no severe adverse events where found. There are a few minor side effects including skin irritation, a phosphene at the start of stimulation, nausea, headache, dizziness, and itching under the electrode. A recent study of over 500 subjects using the currently accepted protocol reported only a slight skin irritation and a phosphene as side effects. Patients can benefit from a significant improvement of invalidant symptoms but also of their quality of life. To ensure safety, patients will be accompanied throughout the protocol by professionals trained in the management of their disease. Besides the protocol procedure, patients will be supported, in all centers, according to the international recommendations in terms of safety and practice. Patients receiving placebo procedure after randomization will pursue pharmacological treatment and usual health care.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators will enroll 150 subjects comprising three population groups SZ, At Risk and HS.) Immediately after inclusion, participants will be randomized into 2 equal groups via random generation of two binary integer's reflecting tDCS-treatment condition or the tDCS control (sham) resulting in random allocation into one of 2 study arms. This randomization will be stratified per population group to insure that both conditions are equally reflected across all three groups.
| Arm | Type | Receives |
|---|---|---|
| transcranial Direct Current Stimulation ( tDCS ) | Active comparator | Device: transcranial Direct Current Stimulation tDCSIntensity : 1,5mA Duration : 20 minutes stimulation over frontal (F3/F4) electrodes |
| transcranial Direct Current Stimulation ( tDCS) | Sham comparator | Device: transcranial Direct Current Stimulation tDCSIntensity : 1,5mA Duration : 20 minutes stimulation over parietal(CP3 CP4) electrodes |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- be between 18 and 45-years-old
- have normal hearing assessed by the Five-minute hearing test
- have French as a first language
- be able to provide written informed consent
- be right handed as measured by the Edinburgh handedness scale
Key exclusion criteria (6 listed)
- significant medical or neurological illness or history of fetal alcohol exposure that may increase risks of the study, significantly affect brain function, or impede participation
- substance dependence (except nicotine) or abuse not in remission within the past six months or recent use presenting the possibility of acute intoxication or withdrawal
- a history of any Axis I psychiatric disorder except those required in the inclusion criteria, any history of pervasive developmental disorder or mental retardation
- for Visit 3: If participating in tCDS Contraindications for tDCS (pacemaker or brain stimulator) and/or MRI (neurologic stimulator, pacemaker, cardiac defibrillator, cardiac prosthesis, vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid derivation, metallic splinters in the eyes)
- patients under curatorship/guardianship and whose clinical condition requires inpatient procedure under constraint
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 |
|---|---|---|
| transcranial Direct Current Stimulation tDCS75 participants will receive 20 minutes of active tDCS (1,5mA, 20 minutes stimulation over frontal (F3/F4) electrodes ); A group of 75 participants will receive 1,5mA 20 minutes of stimulation over parietal (CP3 CP4) electrodes. During this stimulation session and we will also measure your ability to perceive visual and auditory objects presented by a computer, while recording your brain activity using electroencephalography or EEG (a technique using electrodes that measures the electrical activity of your brain) | Device | transcranial Direct Current Stimulation ( tDCS ), transcranial Direct Current Stimulation ( tDCS) |
Primary outcome
Causation Task - testing time based causal judgments
Time frame: 3 months
Primary metric: threshold defined as the smallest time difference (in 16.7ms increments) at which subject judge ball movement "B" to be caused by the impact of ball "A" 75% of the time.
Triangle Task - measuring the extent to which temporal coincidence is used to infer causality in a social situation
Time frame: 3 months
Primary metric: threshold of tolerated relational time delay (levels in 16.7ms increments) between interacting visual figures (i.e triangles), under which participants reliably (at 75%) perceive social agency or social interactions.
3 secondary outcomes
EEG Task 1, Time visual oddball task - for measuring electrophysiological markers of active temporal (time) deviance detection
Time frame: 3 months
EEG Task 2, Covert visual simultaneity task - an exploratory task designed to model the visual Simultaneity behavioral task
Time frame: 3 months
Resting state oscillatory structure
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
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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.
POULET EMMANUEL, MD - PhD principal investigator
CH LE VINATIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial Direct Current Stimulation tDCS in people with Behaviors and Mental Disorders, run by Hôpital le Vinatier at 1 site in France.
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 9 inclusion and 6 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: withdrawn, as of the sponsor's last update on 22 Apr 2019. 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 France. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Causation Task - testing time based causal judgments (time frame: 3 months). The study lists 2 primary outcomes in all. 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 22 Apr 2019.