Social Cognition in Patients With SchizophreniaTBS-COGNCT02479919
Treating Social Cognition With Theta Burst Stimulation: a Multicentric Study
A study testing Magstim® Active TBS in people with Social Cognition in Patients With Schizophrenia, run by University Hospital, Caen at 3 sites in France.
Trial summary
The purpose of the study is to test a new treatment of social cognition deficits in patients with schizophrenia or schizoaffective disorder by transcranial magnetic stimulation (theta-burst). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Social Cognition in Patients With Schizophrenia
- What is being tested?
- Magstim® Active TBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 3 sitesFrance
- Study dates
- 11 Apr 2017to Mar 2023
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- with a diagnosis of schizophrenia or schizoaffective disorder (DSM-IV MINI R)
- Having signed a written informed consent
- 'Lecture Intentionnelle en situation' (LIS) score > 15 or negative 'Positive and Negative Syndrome Scale' (PANSS) score > 15
Who cannot join
- Any change in psychotropic drugs (antidepressants, antipsychotics or mood stabilizers) during the two months preceding the inclusion
- Pregnant or breastfeeding women
- Subjects with a neurological condition or with epilepsy
- Subjects with a counter-indication to MRI or Transcranial stimulation (electronic or metal implants)
- Subjects that refuse to wear earplugs during MRI
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Dollfus
Caen, 14000
Sonia Dollfus, Pr, +33231065018, dollfus@cyceron.fr
Céline Margrite, +33231065018, margrite-c@chu-caen.fr
- Recruiting
Jaafari
Poitiers
Nemat Jaafari, Pr, nemat.jaafari@ch-poitiers.fr
- Recruiting
Guillin
Sotteville-lès-Rouen
Olivier Guillin, Pr, olivier.guillin@ch-lerouvray.fr
About this study
Official title: Treating Social Cognition Impairments in Patients With Schizophrenia With Repetitive Transcranial Magnetic Stimulation (Theta-Burst; TBS); a Multicentric Study
The purpose of the study is to test a new treatment of social cognition deficits in patients with schizophrenia or schizoaffective disorder by transcranial magnetic stimulation (theta-burst). The study will also identify clinical, psychomotor and cognitive variables that are the most sensitive to treatment, and estimate the most sensitive treatment target between patients.
Read the detailed description
The language understanding of other people is based on linguistic decoding mechanisms (phonological, semantic, syntactic ...) but also more on subtle mechanisms for the recognition of emotions and intentions. Interact with another one requires understanding its language but also to infer emotions and intentions. There are patients with schizophrenia suffering from social cognition disorders that impair social interactions; These patients often have difficulty in extracting the non-verbal emotional content of language and have difficulty inferring the thoughts and intentions of others. Recently, investigators have suggested a link between such deficits and the hypofunction of the medial prefrontal cortex.
Transcranial magnetic stimulation is a noninvasive neuromodulation technique that increases or decreases the focal cortical excitability depending on stimulation parameters. This technique is now commonly used as a therapeutic tool. It has been tried with some success in patients with schizophrenia in some indications:
- To reduce the auditory verbal hallucinations stimulating the temporal cortex
- More rarely, to reduce the negative symptoms stimulating the dorsolateral prefrontal cortex.
So far, the medial prefrontal cortex was not considered as a possible target as the scalp to cortex distance prevent from using conventional stimulation coils. Recently new coils have been developed that permit stimulation of deeper cortical regions.
Investigators hypothesize that the use of transcranial magnetic stimulation with a theta burst intermittent protocol known to increase the cortical excitability and aiming the medial prefrontal cortex with a special antenna will improve social interaction capabilities of schizophrenic patients.
In this multicentric study, involving 61 patients, investigators plan to assess the social cognition deficits before and after 10 sessions of magnetic stimulation (2 sessions per day for 5 consecutive days) using a neuronavigation system and Magstim® stimulator. In order to assess the specificity of the stimulation of medial prefrontal cortex (MPC), the effects of this treatment will be compared to the effects of the same treatment aiming the dorsolateral prefrontal cortex (DLPFC), also involved in aspects of negative symptoms of schizophrenia, and placebo effects induced by sham stimulation (using a sham coil). An anatomical MRI will be performed before the treatment to define the targets. Moreover, changes motor activity will be observed after stimulation thanks to continuous actimetry recording.
- Being tested
- Magstim® Active TBS, Magstim® Sham TBS
- Keywords
- theta burst stimulation, Social Cognition, Schizophrenia, transcranial magnetic stimulation
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magstim® Active TBSDevice
Non-invasive transcranial magnetic stimulation inducing changes in cortical excitability depending on the cortical target (except for sham stimulation)
Magstim® Sham TBSDevice
Sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| TBS-MPC | Experimental | Intervention with Magstim® Active TBS aiming Medial Prefrontal Cortex in 18 patients with schizophrenia Receives: Device: Magstim® Active TBS |
| TBS-CPDLF | Active comparator | Intervention with Magstim® Active TBS aiming Dorsolateral Prefrontal Cortex in 18 patients with schizophrenia Receives: Device: Magstim® Active TBS |
| TBS-Sham | Sham comparator | Intervention with Magstim® Sham TBS in 25 patients with schizophrenia Receives: Device: Magstim® Sham TBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
V-LIS total score
Measured: change from baseline in V-LIS total score compared to 30 days after the end of the treatment
Secondary outcomes (1)
Motor activity measured with an actimeter
Measured: change in baseline motor activity measured with an actimeter compared to 30 days after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study start11 Apr 2017
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Cognition in Patients With SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Rouen, Centre Hospitalier Universitaire Dijon, Poitiers University Hospital
- Responsible party
- Sponsor
- Investigators
- Sonia Dollfus, Pr, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479919
- Sponsor's protocol ID
- 2015-A00424-45
- Acronym
- TBS-COG
- Status last verified
- Mar 2022
- First submitted
- 2 Jun 2015
- Last updated
- 9 Mar 2022
- 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 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Social Cognition Impairments in Patients With Schizophrenia With Repetitive Transcranial Magnetic Stimulation (Theta-Burst; TBS); a Multicentric Study
- ClinicalTrials.gov ID
- NCT02479919
- Acronym / sponsor ID
- TBS-COG / 2015-A00424-45
- Keywords
- theta burst stimulation, Social Cognition, Schizophrenia, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- University Hospital, Rouen, Centre Hospitalier Universitaire Dijon, Poitiers University Hospital
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 24 Jun 2015 (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.
The purpose of the study is to test a new treatment of social cognition deficits in patients with schizophrenia or schizoaffective disorder by transcranial magnetic stimulation (theta-burst). The study will also identify clinical, psychomotor and cognitive variables that are the most sensitive to treatment, and estimate the most sensitive treatment target between patients.
Detailed description
The language understanding of other people is based on linguistic decoding mechanisms (phonological, semantic, syntactic ...) but also more on subtle mechanisms for the recognition of emotions and intentions. Interact with another one requires understanding its language but also to infer emotions and intentions. There are patients with schizophrenia suffering from social cognition disorders that impair social interactions; These patients often have difficulty in extracting the non-verbal emotional content of language and have difficulty inferring the thoughts and intentions of others. Recently, investigators have suggested a link between such deficits and the hypofunction of the medial prefrontal cortex.
Transcranial magnetic stimulation is a noninvasive neuromodulation technique that increases or decreases the focal cortical excitability depending on stimulation parameters. This technique is now commonly used as a therapeutic tool. It has been tried with some success in patients with schizophrenia in some indications:
- To reduce the auditory verbal hallucinations stimulating the temporal cortex
- More rarely, to reduce the negative symptoms stimulating the dorsolateral prefrontal cortex.
So far, the medial prefrontal cortex was not considered as a possible target as the scalp to cortex distance prevent from using conventional stimulation coils. Recently new coils have been developed that permit stimulation of deeper cortical regions.
Investigators hypothesize that the use of transcranial magnetic stimulation with a theta burst intermittent protocol known to increase the cortical excitability and aiming the medial prefrontal cortex with a special antenna will improve social interaction capabilities of schizophrenic patients.
In this multicentric study, involving 61 patients, investigators plan to assess the social cognition deficits before and after 10 sessions of magnetic stimulation (2 sessions per day for 5 consecutive days) using a neuronavigation system and Magstim® stimulator. In order to assess the specificity of the stimulation of medial prefrontal cortex (MPC), the effects of this treatment will be compared to the effects of the same treatment aiming the dorsolateral prefrontal cortex (DLPFC), also involved in aspects of negative symptoms of schizophrenia, and placebo effects induced by sham stimulation (using a sham coil). An anatomical MRI will be performed before the treatment to define the targets. Moreover, changes motor activity will be observed after stimulation thanks to continuous actimetry recording.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TBS-MPC | Experimental | Device: Magstim® Active TBSIntervention with Magstim® Active TBS aiming Medial Prefrontal Cortex in 18 patients with schizophrenia |
| TBS-CPDLF | Active comparator | Device: Magstim® Active TBSIntervention with Magstim® Active TBS aiming Dorsolateral Prefrontal Cortex in 18 patients with schizophrenia |
| TBS-Sham | Sham comparator | Device: Magstim® Sham TBSIntervention with Magstim® Sham TBS in 25 patients with schizophrenia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- with a diagnosis of schizophrenia or schizoaffective disorder (DSM-IV MINI R)
- Having signed a written informed consent
- 'Lecture Intentionnelle en situation' (LIS) score > 15 or negative 'Positive and Negative Syndrome Scale' (PANSS) score > 15
Key exclusion criteria (5 listed)
- Any change in psychotropic drugs (antidepressants, antipsychotics or mood stabilizers) during the two months preceding the inclusion
- Pregnant or breastfeeding women
- Subjects with a neurological condition or with epilepsy
- Subjects with a counter-indication to MRI or Transcranial stimulation (electronic or metal implants)
- Subjects that refuse to wear earplugs during MRI
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 |
|---|---|---|
| Magstim® Active TBSNon-invasive transcranial magnetic stimulation inducing changes in cortical excitability depending on the cortical target (except for sham stimulation) | Device | TBS-CPDLF, TBS-MPC |
| Magstim® Sham TBSSham stimulation | Device | TBS-Sham |
Primary outcome
V-LIS total score
Time frame: change from baseline in V-LIS total score compared to 30 days after the end of the treatment
1 secondary outcome
Motor activity measured with an actimeter
Time frame: change in baseline motor activity measured with an actimeter compared to 30 days after the end of the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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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.
Sonia Dollfus, Pr principal investigator
University Hospital, Caen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magstim® Active TBS in people with Social Cognition in Patients With Schizophrenia, run by University Hospital, Caen at 3 sites 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 3 inclusion and 5 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 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sonia Dollfus, Pr ((0)231065018 ext. +33, dollfus@cyceron.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
V-LIS total score (time frame: change from baseline in V-LIS total score compared to 30 days after the end of the treatment). 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 9 Mar 2022.