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Treating Social Cognition With Theta Burst Stimulation; a Pilot Sudy (PilotTMS-COG)

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ClinicalTrials.gov Identifier: NCT02440867
Recruitment Status : Unknown
Verified July 2017 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : May 12, 2015
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
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 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.

Condition or disease Intervention/treatment Phase
Social Cognition in Patients With Schizophrenia Device: Active TBS Device: Sham TBS Not Applicable

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, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Social Cognition Impairments in Patients With Schizophrenia With Repetitive Transcranial Magnetic Stimulation (Theta-Burst; TBS); a Pilot Study
Study Start Date : May 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
No Intervention: Healthy subjects
Multimodal imaging data acquisitions Clinical data acquisitions
Experimental: TBS-MPC
  • Intervention with active TBS aiming Medial Prefrontal Cortex in 6 patients with schizophrenia
  • Baseline: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition
  • Endpoint: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition
  • Continuous actimetry acquisition
Device: Active TBS
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 active TBS aiming Dorsolateral Prefrontal Cortex in 6 patients with schizophrenia
  • Baseline: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition
  • Endpoint: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition
  • Continuous actimetry acquisition
Device: Active TBS
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 Sham TBS in 8 patients with schizophrenia
  • Baseline: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition
  • Endpoint: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition
  • Continuous actimetry acquisition
Device: Sham TBS
Sham stimulation




Primary Outcome Measures :
  1. V-LIS total score [ Time Frame: change from baseline in V-LIS total score compared to 30 days after the end of the treatment ]

Secondary Outcome Measures :
  1. GLX ratio [ Time Frame: change in baseline GLX ratio measured in MRSI compared to 30 days after the end of the treatment ]
    GLX (= Glutamine + Glutamate) ratio are measured in the DLPFC and in the MPC

  2. P50 wave amplitude [ Time Frame: change in baseline P50 amplitude compared to immediately after the end of the treatment ]
  3. Motor activity [ Time Frame: change in baseline motor activity measured with an actimeter compared to 30 days after the end of the treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • with a diagnosis of schizophrenia or schizoaffective disorder (DSM-IV MINI R)
  • less than 20 years of disease duration
  • Having signed a written informed consent
  • LIS score > 15 or negative 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440867


Contacts
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Contact: Clement Nathou, MD (0)231065018 ext +33 nathou@chu-caen.fr
Contact: Sonia Dollfus, MD, PhD (0)231065018 ext +33 dollfus@chu-caen.fr

Locations
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France
CHU de Caen - Centre Esquirol Recruiting
Caen, France, 14033
Contact: Clément Nathou, Dr.    +33231065018    nathou-c@chu-caen.fr   
Sponsors and Collaborators
University Hospital, Caen
Investigators
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Principal Investigator: Clément Nathou, MD University Hospital, Caen
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02440867    
Other Study ID Numbers: 2014-A00839-38
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Keywords provided by University Hospital, Caen:
theta burst stimulation
Social Cognition
MRSI
Schizophrenia
transcranial magnetic stimulation
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders