Treating Social Cognition With Theta Burst Stimulation: a Multicentric Study

Not Applicable

• Conditions: Social Cognition in Patients With Schizophrenia
• Interventions: Device: Magstim® Active TBS; Device: Magstim® Sham TBS

• Registration Number: NCT02479919
• Lead Sponsor: University Hospital, Caen

Brief 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). 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 Timeline

• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-24
• Study Start: 2017-04-11
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-09
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TBS-CPDLF	Magstim® Active TBS	Intervention with Magstim® Active TBS aiming Dorsolateral Prefrontal Cortex in 18 patients with schizophrenia
TBS-Sham	Magstim® Sham TBS	Intervention with Magstim® Sham TBS in 25 patients with schizophrenia
TBS-MPC	Magstim® Active TBS	Intervention with Magstim® Active TBS aiming Medial Prefrontal Cortex in 18 patients with schizophrenia

Primary Outcome Measures

Name	Time	Method
V-LIS total score	change from baseline in V-LIS total score compared to 30 days after the end of the treatment

Secondary Outcome Measures

Name	Time	Method
Motor activity measured with an actimeter	change in baseline motor activity measured with an actimeter compared to 30 days after the end of the treatment

Trial Locations

Locations (3)

Jaafari; 🇫🇷 Poitiers, France

Dollfus; 🇫🇷 Caen, France

Guillin; 🇫🇷 Sotteville-lès-Rouen, France