• Treating Social Cognition With Theta Burst Stimulation; a Pilot Sudy

  NCT02440867

  Unknown statusInterventionalNot ApplicableUpdated Jul 21, 2017
• Repetitive Transcranial Magnetic Stimulation and Intermittent Theta Burst (iTBS) in Schizophrenia

  NCT01315587

  Unknown statusInterventionalPhase 2Updated Sep 1, 2015
• Cerebellar Modulation of Cognition in Psychosis

  NCT06107764

  RecruitingInterventionalNot ApplicableUpdated Aug 20, 2026
• Brain Stimulation to the Hippocampus in Schizophrenia

  NCT07010614

  RecruitingInterventionalNot ApplicableUpdated Feb 27, 2026
• Theta Burst Stimulation for Schizophrenia

  NCT03288779

  CompletedInterventionalNot ApplicableUpdated Nov 25, 2019
• Neuromodulation of Social Cognitive Circuitry in People With Schizophrenia Spectrum Disorders

  NCT04418011

  CompletedInterventionalNot ApplicableUpdated Oct 17, 2023

ClinicalTrials.gov ID

NCT02479919

Lead Sponsor

University Hospital, CaenOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

61Estimated

Last Update Posted

Mar 9, 2022Actual

Start Date

Apr 11, 2017Actual

Primary Completion Date

Mar 2023Estimated

Completion Date

Mar 2023Estimated

Official Title

Treating Social Cognition Impairments in Patients With Schizophrenia With Repetitive Transcranial Magnetic Stimulation (Theta-Burst; TBS); a Multicentric Study

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.

• Social Cognition in Patients With Schizophrenia

• Magstim® Active TBS
• Magstim® Sham TBS

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

University Hospital, CaenOTHER

Collaborators

University Hospital, RouenOTHER

Centre Hospitalier Universitaire DijonOTHER

Poitiers University HospitalOTHER

nemat.jaafari@ch-poitiers.fr