Multimodal MRI-guided rTMS to Treat Refractory Hallucinations

University Hospital, Lille85 enrolled

Overview

* The efficacy of neuro-navigated rTMS for patients with schizophrenia suffering from drug-resistant multisensory hallucinations will be tested by the implementation of a double-blind randomized controlled trial (RCT) * This study will use a combination of different MRI modalities (fMRI and DTI) to define with precision rTMS brain-targets in the case of multisensory hallucinations * The investigators anticipate that multimodal MRI-guided rTMS will allow a significant improvement in the efficacy of neuromodulation treatment of refractory hallucinations

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hallucinations Schizophrenia Perceptual Disorders

Interventions

Eligibility

Sex: ALLMin age: 13 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Right-handed Female/Male, \[13-60 y.o.\], * Schizophrenia (DSM-IV-TR diagnosis), * Drug-resistant hallucinations (Kinon \& Kane criteria, 1993), * Unmodified antipsychotic dosage during the 30 days preceding rMTS, * No anticonvulsive medication, * No neurological disorder, no addictive behavior, * Matched for sex, age and PANSS scores, * Consent to participate to the study, Exclusion Criteria: * Pregnancy * Contraindication to MRI scan * Contraindication to rTMS treatment * Claustrophobia * No social insurance

Locations (2)

Lille University Hospital Centre

Lille, France

Saint-Anne Psychiatric Hospital

Paris, France

Outcomes

Primary Outcomes

Severity and Frequency of Hallucinations

Visual Analogue Scale (Severity)/ Visual Analogue Scale (Frequency rate)

Time frame: Assessed at baseline (t0) and longitudinally after the 10 rTMS sessions during the following month (D+15, M+1, M+3, M+6, M+12)

Secondary Outcomes

Clinical State

Clinical Global Improvement \[CGI\]/ Positive \& Negative Symptoms Scale \[PANSS\]/ Global Assessment of Functioning \[GAF\]. For the auditory modality: Add the Auditory Hallucinations rating Scale \[AHRS\] frequency scale and total score/ Add the computerized Binary Scale of Auditory Speech Hallucinations \[cbSASH\]

Time frame: Assessed at baseline (t0) and longitudinally after the 10 rTMS sessions during the following month (D+15, M+1, M+3, M+6, M+12)

MRI changes

structural MRI/ functional MRI/ Diffusion Tensor Imaging/ MR-spectroscopy

Time frame: Assessed at baseline (t0) and 1 month after the rTMS sessions (M+1)