Multimodal MRI-guided rTMS to Treat Refractory Hallucinations (MULTIMODHAL)

University Hospital, Lille

Status: Completed

Conditions: Perceptual Disorders; Schizophrenia; Hallucinations

Treatments: Device: MagPro X100 repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01373866

2009-A00842-55 (Other Identifier)

2009_17/0927

Details and patient eligibility

About

• 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

Enrollment: 85 patients

Sex: All

Ages: 13 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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85 participants in 2 patient groups

Multimodal MRI-guided rTMS

Experimental group

Treatment:

Device: MagPro X100 repetitive Transcranial Magnetic Stimulation

Device: MagPro X100 repetitive Transcranial Magnetic Stimulation

Conventional T3-P3 rTMS

Active Comparator group

Treatment:

Device: MagPro X100 repetitive Transcranial Magnetic Stimulation

Device: MagPro X100 repetitive Transcranial Magnetic Stimulation