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

This study is currently recruiting participants. (see Contacts and Locations)

Verified May 2016 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 12, 2016

Last verified: May 2016

History of Changes

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:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

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 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


Ages Eligible for Study:	13 Years to 60 Years (Child, Adult)
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


Responsible Party:	University Hospital, Lille
ClinicalTrials.gov Identifier:	NCT01373866 History of Changes
Other Study ID Numbers:	2009_17/0927 2009-A00842-55
Study First Received:	May 13, 2011
Last Updated:	May 12, 2016
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 Spectrum and Other Psychotic Disorders Mental Disorders	Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2016

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