Multimodal MRI-guided rTMS to Treat Refractory Hallucinations

* 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hallucinations Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

13 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lille University Hospital Centre, Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MagPro X100 repetitive Transcranial Magnetic Stimulation

Device

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

Primary outcomes

Severity and Frequency of Hallucinations

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)

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

Secondary outcomes

Clinical State

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)

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

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

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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Multimodal MRI-guided Repetitive Transcranial Magnetic Stimulation to Treat Drug-resistant Hallucinations: a Randomized Control Trial

Acronym: MULTIMODHAL

Important dates

Study start: 2010
Primary completion: 2022
Study completion: 2022
First posted: Jun 15, 2011
Registry last updated: Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed