Treating Social Cognition With Theta Burst Stimulation: a Multicentric Study (TBS-COG)

March 8, 2022 updated by: University Hospital, Caen

Treating Social Cognition Impairments in Patients With Schizophrenia With Repetitive Transcranial Magnetic Stimulation (Theta-Burst; TBS); a Multicentric 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, psychomotor and cognitive variables that are the most sensitive to treatment, and estimate the most sensitive treatment target between patients.

Study Overview

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

Interventional

Enrollment (Anticipated)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Caen, France, 14000
        • Recruiting
        • Dollfus
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Camille Delouche, MD
      • Poitiers, France
        • Recruiting
        • Jaafari
      • Sotteville-lès-Rouen, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sonia Dollfus, Pr, University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2017

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

June 2, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Social Cognition in Patients With Schizophrenia

Clinical Trials on Magstim® Active TBS

3
Subscribe