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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Hospital, Lille
Sponsor:
Information provided by (Responsible Party):
Renaud JARDRI, University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01373866
First received: May 13, 2011
Last updated: March 2, 2014
Last verified: March 2014

May 13, 2011
March 2, 2014
November 2010
November 2014   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Visual Analogue Scale (Severity)/ Visual Analogue Scale (Frequency rate)
Same as current
Complete list of historical versions of study NCT01373866 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    structural MRI/ functional MRI/ Diffusion Tensor Imaging/ MR-spectroscopy
Same as current
Not Provided
Not Provided
 
Multimodal MRI-guided rTMS to Treat Refractory Hallucinations
Multimodal MRI-guided Repetitive Transcranial Magnetic Stimulation to Treat Drug-resistant Hallucinations: a Randomized Control Trial
  • 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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
  • Hallucinations
  • Schizophrenia
  • Perceptual Disorders
  • 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

  • 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
  • Experimental: Multimodal MRI-guided rTMS
    Intervention: Device: MagPro X100 repetitive Transcranial Magnetic Stimulation
  • Active Comparator: Conventional T3-P3 rTMS
    Intervention: Device: MagPro X100 repetitive Transcranial Magnetic Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
13 Years to 60 Years
No
Contact: Renaud Jardri, M.D., Ph.D. renaud.jardri@chru-lille.fr
France
 
NCT01373866
2009-A00842-55, 2009_17/0927
Yes
Renaud JARDRI, University Hospital, Lille
University Hospital, Lille
Not Provided
Principal Investigator: Renaud Jardri, M.D., Ph.D. Lille University Medical Centre, France
University Hospital, Lille
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP