Social Cognition in Patients With Schizophrenia Clinical Trial
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02479919 -
Treating Social Cognition With Theta Burst Stimulation: a Multicentric Study
|
N/A |