Multimodal MRI-guided rTMS to Treat Refractory Hallucinations (MULTIMODHAL)
This study is currently recruiting participants.
Verified May 2011 by University Hospital, Lille
Sponsor:
University Hospital, Lille
Information provided by:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01373866
First received: May 13, 2011
Last updated: June 14, 2011
Last verified: May 2011
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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: Magstim Rapid2 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 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Multimodal MRI-guided rTMS |
Device: Magstim Rapid2 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: Magstim Rapid2 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 | |
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: | JARDRI Renaud (PI), Lille University Medical Centre |
| 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: | June 14, 2011 |
| 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 May 23, 2013