Social Cognition in Patients With SchizophreniaPilotTMS-COGNCT02440867
Treating Social Cognition With Theta Burst Stimulation; a Pilot Sudy
A study testing Active TBS in people with Social Cognition in Patients With Schizophrenia, run by University Hospital, Caen at 1 site 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 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Cognition in Patients With Schizophrenia
- What is being tested?
- Active TBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Dec 2018
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- with a diagnosis of schizophrenia or schizoaffective disorder (DSM-IV MINI R)
- less than 20 years of disease duration
- Having signed a written informed consent
- LIS score > 15 or negative 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
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Caen - Centre Esquirol
Caen, 14033
Clément Nathou, Dr., +33231065018, nathou-c@chu-caen.fr
About this study
Official title: Treating Social Cognition Impairments in Patients With Schizophrenia With Repetitive Transcranial Magnetic Stimulation (Theta-Burst; TBS); a Pilot 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 variables, cognitive and psychomotor most sensitive to treatment, to estimate the most sensitive treatment target, assess tolerance, to assess the impact of repetitive Transcranial Magnetic Stimulation (rTMS) on the brain a multimodal imaging study and compare the imaging variables (resting network, Diffusion Tensor Imaging, magnetic resonance spectroscopic imaging; MRSI) between patients before treatment and healthy subjects.
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, we 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.
We 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.
This ambitious and innovative assumption shall be first supported by a study of feasibility which is the subject of this trial.
Moreover, changes in the anatomical and functional connectivity, in brain metabolism and in cortical excitability will be observed after stimulation thanks to a multimodal imaging and the study of P50 wave.
In this pilot study, involving 20 patients, we 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 feasibility and 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). The recording of the P50 wave will be just before and after the 1st session and just after the last stimulation session. An MRI anatomical, functional and spectroscopic be performed before and 30 days after the treatment. A control group of twenty healthy subjects will perform the same MRI acquisitions.
- Being tested
- Active TBS, Sham TBS
- Keywords
- theta burst stimulation, Social Cognition, MRSI, 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.
Active TBSDevice
Non-invasive transcranial magnetic stimulation inducing changes in cortical excitability depending on the cortical target (except for sham stimulation)
Sham TBSDevice
Sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | No intervention | Multimodal imaging data acquisitions Clinical data acquisitions |
| TBS-MPC | Experimental | * Intervention with active TBS aiming Medial Prefrontal Cortex in 6 patients with schizophrenia
* Baseline: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition
* Endpoint: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition
* Continuous actimetry acquisition Receives: Device: Active TBS |
| TBS-CPDLF | Active comparator | * Intervention with active TBS aiming Dorsolateral Prefrontal Cortex in 6 patients with schizophrenia
* Baseline: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition
* Endpoint: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition
* Continuous actimetry acquisition Receives: Device: Active TBS |
| TBS-Sham | Sham comparator | * Intervention with Sham TBS in 8 patients with schizophrenia
* Baseline: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition
* Endpoint: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition
* Continuous actimetry acquisition Receives: Device: 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 (3)
GLX ratio
GLX (= Glutamine + Glutamate) ratio are measured in the DLPFC and in the MPC
Measured: change in baseline GLX ratio measured in MRSI compared to 30 days after the end of the treatment
P50 wave amplitude
Measured: change in baseline P50 amplitude compared to immediately after the end of the treatment
Motor activity
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 posted12 May 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clément Nathou, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440867
- Sponsor's protocol ID
- 2014-A00839-38
- Acronym
- PilotTMS-COG
- Status last verified
- Jul 2017
- First submitted
- 4 May 2015
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. 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 Pilot Study
- ClinicalTrials.gov ID
- NCT02440867
- Acronym / sponsor ID
- PilotTMS-COG / 2014-A00839-38
- Keywords
- theta burst stimulation, Social Cognition, MRSI, Schizophrenia, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 12 May 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 variables, cognitive and psychomotor most sensitive to treatment, to estimate the most sensitive treatment target, assess tolerance, to assess the impact of repetitive Transcranial Magnetic Stimulation (rTMS) on the brain a multimodal imaging study and compare the imaging variables (resting network, Diffusion Tensor Imaging, magnetic resonance spectroscopic imaging; MRSI) between patients before treatment and healthy subjects.
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, we 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.
We 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.
This ambitious and innovative assumption shall be first supported by a study of feasibility which is the subject of this trial.
Moreover, changes in the anatomical and functional connectivity, in brain metabolism and in cortical excitability will be observed after stimulation thanks to a multimodal imaging and the study of P50 wave.
In this pilot study, involving 20 patients, we 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 feasibility and 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). The recording of the P50 wave will be just before and after the 1st session and just after the last stimulation session. An MRI anatomical, functional and spectroscopic be performed before and 30 days after the treatment. A control group of twenty healthy subjects will perform the same MRI acquisitions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | No intervention | –Multimodal imaging data acquisitions Clinical data acquisitions |
| TBS-MPC | Experimental | Device: Active TBS* Intervention with active TBS aiming Medial Prefrontal Cortex in 6 patients with schizophrenia * Baseline: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition * Endpoint: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition * Continuous actimetry acquisition |
| TBS-CPDLF | Active comparator | Device: Active TBS* Intervention with active TBS aiming Dorsolateral Prefrontal Cortex in 6 patients with schizophrenia * Baseline: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition * Endpoint: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition * Continuous actimetry acquisition |
| TBS-Sham | Sham comparator | Device: Sham TBS* Intervention with Sham TBS in 8 patients with schizophrenia * Baseline: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition * Endpoint: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition * Continuous actimetry acquisition |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- with a diagnosis of schizophrenia or schizoaffective disorder (DSM-IV MINI R)
- less than 20 years of disease duration
- Having signed a written informed consent
- LIS score > 15 or negative 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 |
|---|---|---|
| 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 |
| 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
3 secondary outcomes
GLX ratio
Time frame: change in baseline GLX ratio measured in MRSI compared to 30 days after the end of the treatment
P50 wave amplitude
Time frame: change in baseline P50 amplitude compared to immediately after the end of the treatment
Motor activity
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 21 Jul 2017.
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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.
Clément Nathou, MD principal investigator
University Hospital, Caen
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 TBS in people with Social Cognition in Patients With Schizophrenia, run by University Hospital, Caen 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 4 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 21 Jul 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clement Nathou, MD ((0)231065018 ext. +33, nathou@chu-caen.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 21 Jul 2017.