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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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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

Condition or disease Intervention/treatment Phase
Hallucinations Schizophrenia Perceptual Disorders Device: MagPro X100 repetitive Transcranial Magnetic Stimulation Not Applicable

Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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]


  2. 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


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Renaud Jardri, M.D., Ph.D. renaud.jardri@chru-lille.fr

Locations
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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   
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Renaud Jardri, M.D., Ph.D. Lille University Medical Centre, France
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Repetitive Transcranial Magnetic Stimulation
Neuronavigation
Functional Magnetic Resonance Imaging
Diffusion Tensor Imaging
Additional relevant MeSH terms:
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Hallucinations
Perceptual Disorders
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
 Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases