Hallucinations, Perceptual Disorders, Schizophrenia
Conditions
Keywords
Repetitive Transcranial Magnetic Stimulation, Neuronavigation, Functional Magnetic Resonance Imaging, Diffusion Tensor Imaging
Brief summary
* 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
Interventions
DEVICEMagPro X100 repetitive Transcranial Magnetic Stimulation
Target defined using both fMRI during hallucinations occurence and tractography. Parameters: 1 Hz/ 100% of the Motor Threshold/ 10 sessions (2/ day over 5 days)/ 1200 pulses/ session
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity and Frequency of Hallucinations | 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) | Visual Analogue Scale (Severity)/ Visual Analogue Scale (Frequency rate) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical State | 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) | 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 \[cbSASH\] |
| MRI changes | Assessed at baseline (t0) and 1 month after the rTMS sessions (M+1) | structural MRI/ functional MRI/ Diffusion Tensor Imaging/ MR-spectroscopy |
Countries
France
Outcome results
None listed