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

January 25, 2024 updated by: University Hospital, Lille

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, F-59037
        • Lille University Hospital Centre
      • Paris, France, 75005
        • Saint-Anne Psychiatric Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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
Active Comparator: Conventional T3-P3 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
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)
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
Assessed at baseline (t0) and 1 month after the rTMS sessions (M+1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Renaud Jardri, M.D., Ph.D., Lille University Medical Centre, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2010

Primary Completion (Actual)

February 11, 2022

Study Completion (Actual)

February 11, 2022

Study Registration Dates

First Submitted

May 13, 2011

First Submitted That Met QC Criteria

June 14, 2011

First Posted (Estimated)

June 15, 2011

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009_17/0927
  • 2009-A00842-55 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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