- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02479919
Treating Social Cognition With Theta Burst Stimulation: a Multicentric Study (TBS-COG)
Treating Social Cognition Impairments in Patients With Schizophrenia With Repetitive Transcranial Magnetic Stimulation (Theta-Burst; TBS); a Multicentric Study
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sonia Dollfus, Pr
- Phone Number: +33 (0)231065018
- Email: dollfus@cyceron.fr
Study Contact Backup
- Name: Céline Margrite
- Phone Number: +33 (0)231065018
- Email: margrite-c@chu-caen.fr
Study Locations
-
-
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Caen, France, 14000
- Recruiting
- Dollfus
-
Contact:
- Sonia Dollfus, Pr
- Phone Number: +33231065018
- Email: dollfus@cyceron.fr
-
Contact:
- Céline Margrite
- Phone Number: +33231065018
- Email: margrite-c@chu-caen.fr
-
Sub-Investigator:
- Camille Delouche, MD
-
Poitiers, France
- Recruiting
- Jaafari
-
Sotteville-lès-Rouen, France
- Recruiting
- Guillin
-
Contact:
- Olivier Guillin, Pr
- Email: olivier.guillin@ch-lerouvray.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TBS-MPC
Intervention with Magstim® Active TBS aiming Medial Prefrontal Cortex in 18 patients with schizophrenia
|
Non-invasive transcranial magnetic stimulation inducing changes in cortical excitability depending on the cortical target (except for sham stimulation)
|
Active Comparator: TBS-CPDLF
Intervention with Magstim® Active TBS aiming Dorsolateral Prefrontal Cortex in 18 patients with schizophrenia
|
Non-invasive transcranial magnetic stimulation inducing changes in cortical excitability depending on the cortical target (except for sham stimulation)
|
Sham Comparator: TBS-Sham
Intervention with Magstim® Sham TBS in 25 patients with schizophrenia
|
Sham stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
V-LIS total score
Time Frame: change from baseline in V-LIS total score compared to 30 days after the end of the treatment
|
change from baseline in V-LIS total score compared to 30 days after the end of the treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
change in baseline motor activity measured with an actimeter compared to 30 days after the end of the treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sonia Dollfus, Pr, University Hospital, Caen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-A00424-45
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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