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

This study is currently recruiting participants.
Verified May 2017 by University Hospital, Lille
Sponsor:
ClinicalTrials.gov Identifier:
NCT01373866
First Posted: June 15, 2011
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Lille
  Purpose
  • 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 Intervention
Hallucinations Schizophrenia Perceptual Disorders Device: MagPro X100 repetitive Transcranial Magnetic Stimulation

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 70
Actual Study Start Date: November 15, 2010
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

Locations
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
Principal Investigator: Renaud Jardri, M.D., Ph.D. Lille University Medical Centre, France
  More Information

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01373866     History of Changes
Other Study ID Numbers: 2009_17/0927
2009-A00842-55 ( Other Identifier: ID-RCB number, ANSM )
First Submitted: May 13, 2011
First Posted: June 15, 2011
Last Update Posted: May 19, 2017
Last Verified: May 2017
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

Keywords provided by University Hospital, Lille:
Repetitive Transcranial Magnetic Stimulation
Neuronavigation
Functional Magnetic Resonance Imaging
Diffusion Tensor Imaging

Additional relevant MeSH terms:
Schizophrenia
Hallucinations
Perceptual Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms