Multimodal MRI-guided rTMS to Treat Refractory Hallucinations (MULTIMODHAL)
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ClinicalTrials.gov Identifier: NCT01373866 |
Recruitment Status : Unknown
Verified February 2019 by University Hospital, Lille.
Recruitment status was: Recruiting
First Posted : June 15, 2011
Last Update Posted : February 15, 2019
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- 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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hallucinations Schizophrenia Perceptual Disorders | Device: MagPro X100 repetitive Transcranial Magnetic Stimulation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 70 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Multimodal MRI-guided Repetitive Transcranial Magnetic Stimulation to Treat Drug-resistant Hallucinations: a Randomized Control Trial |
Actual Study Start Date : | November 15, 2010 |
Estimated Primary Completion Date : | November 2019 |
Estimated Study Completion Date : | November 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Multimodal MRI-guided rTMS |
Device: MagPro 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 |
Active Comparator: Conventional T3-P3 rTMS |
Device: MagPro X100 repetitive Transcranial Magnetic Stimulation
Target: T3-P3 (10-20 EEG international System). Parameters: 1 Hz/ 100% of the Motor Threshold/ 10 sessions (2/ day over 5 days)/ 1200 pulses/ session |
- 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)
- 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

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Ages Eligible for Study: | 13 Years to 60 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts 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

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): NCT01373866
Contact: Renaud Jardri, M.D., Ph.D. | renaud.jardri@chru-lille.fr |
France | |
Lille University Hospital Centre | Recruiting |
Lille, France, F-59037 | |
Contact: Renaud JARDRI, M.D., Ph.D. renaud.jardri@chru-lille.fr | |
Saint-Anne Psychiatric Hospital | Recruiting |
Paris, France, 75005 | |
Contact: Marion PLAZE, MD, PhD m.plaze@ch-sainte-anne.fr |
Principal Investigator: | Renaud Jardri, M.D., Ph.D. | Lille University Medical Centre, France |
Responsible Party: | University Hospital, Lille |
ClinicalTrials.gov Identifier: | NCT01373866 |
Other Study ID Numbers: |
2009_17/0927 2009-A00842-55 ( Other Identifier: ID-RCB number, ANSM ) |
First Posted: | June 15, 2011 Key Record Dates |
Last Update Posted: | February 15, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Repetitive Transcranial Magnetic Stimulation Neuronavigation Functional Magnetic Resonance Imaging Diffusion Tensor Imaging |
Hallucinations Perceptual Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders |
Mental Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |