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
  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 Phase
Hallucinations
Schizophrenia
Perceptual Disorders
Device: MagPro X100 repetitive Transcranial Magnetic Stimulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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) ] [ Designated as safety issue: No ]
    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) ] [ 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


Estimated Enrollment: 70
Study Start Date: November 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (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

Ages Eligible for Study:   13 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Renaud JARDRI, Associate Professor in Paediatric Psychiatry, MD, PhD, University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01373866     History of Changes
Other Study ID Numbers: 2009-A00842-55, 2009_17/0927
Study First Received: May 13, 2011
Last Updated: March 2, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 and Disorders with Psychotic Features
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014