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

This study is currently recruiting participants.
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
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:
Hallucinations
Perceptual Disorders
Schizophrenia
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014