Multimodal MRI-guided rTMS to Treat Refractory Hallucinations
NCT ID: NCT01373866
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
85 participants
INTERVENTIONAL
2010-11-15
2022-02-11
Brief Summary
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* 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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Multimodal MRI-guided rTMS
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
Conventional T3-P3 rTMS
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* Contraindication to MRI scan
* Contraindication to rTMS treatment
* Claustrophobia
* No social insurance
13 Years
60 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Renaud Jardri, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Lille University Medical Centre, France
Locations
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Lille University Hospital Centre
Lille, , France
Saint-Anne Psychiatric Hospital
Paris, , France
Countries
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References
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Demeulemeester M, Kochman F, Fligans B, Tabet AJ, Thomas P, Jardri R. Assessing early-onset hallucinations in the touch-screen generation. Br J Psychiatry. 2015 Mar;206(3):181-3. doi: 10.1192/bjp.bp.114.154153.
Leroy A, Foucher JR, Pins D, Delmaire C, Thomas P, Roser MM, Lefebvre S, Amad A, Fovet T, Jaafari N, Jardri R. fMRI capture of auditory hallucinations: Validation of the two-steps method. Hum Brain Mapp. 2017 Oct;38(10):4966-4979. doi: 10.1002/hbm.23707. Epub 2017 Jun 28.
Other Identifiers
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2009-A00842-55
Identifier Type: OTHER
Identifier Source: secondary_id
2009_17/0927
Identifier Type: -
Identifier Source: org_study_id