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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by University Hospital, Lille
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01373866
First received: May 13, 2011
Last updated: May 17, 2017
Last verified: May 2017
May 13, 2011
May 17, 2017
November 15, 2010
November 2017   (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) ]
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) ]

    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
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
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 2017
November 2017   (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
Sexes Eligible for Study: All
13 Years to 60 Years   (Child, Adult)
No
Contact: Renaud Jardri, M.D., Ph.D. renaud.jardri@chru-lille.fr
France
 
 
NCT01373866
2009_17/0927
2009-A00842-55 ( Other Identifier: ID-RCB number, ANSM )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
No
Not Provided
University Hospital, Lille
University Hospital, Lille
Not Provided
Principal Investigator: Renaud Jardri, M.D., Ph.D. Lille University Medical Centre, France
University Hospital, Lille
May 2017

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