Back to results

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

Primary Purpose

Hallucinations, Schizophrenia, Perceptual Disorders

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

MagPro X100 repetitive Transcranial Magnetic Stimulation

About this trial

This is an interventional treatment trial for Hallucinations focused on measuring Repetitive Transcranial Magnetic Stimulation, Neuronavigation, Functional Magnetic Resonance Imaging, Diffusion Tensor Imaging

Eligibility Criteria

13 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Lille University Hospital Centre
Saint-Anne Psychiatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multimodal MRI-guided rTMS

Conventional T3-P3 rTMS

Arm Description

Outcomes

Primary Outcome Measures

Severity and Frequency of Hallucinations

Visual Analogue Scale (Severity)/ Visual Analogue Scale (Frequency rate)

Secondary Outcome Measures

Clinical State

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

structural MRI/ functional MRI/ Diffusion Tensor Imaging/ MR-spectroscopy

Full Information

NCT ID

NCT01373866

First Posted

May 13, 2011

Last Updated

October 27, 2022

Sponsor

University Hospital, Lille

1. Study Identification

Unique Protocol Identification Number

NCT01373866

Brief Title

Multimodal MRI-guided rTMS to Treat Refractory Hallucinations

Acronym

MULTIMODHAL

Official Title

Multimodal MRI-guided Repetitive Transcranial Magnetic Stimulation to Treat Drug-resistant Hallucinations: a Randomized Control Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

November 15, 2010 (Actual)

Primary Completion Date

February 11, 2022 (Actual)

Study Completion Date

February 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hallucinations, Schizophrenia, Perceptual Disorders

Keywords

Repetitive Transcranial Magnetic Stimulation, Neuronavigation, Functional Magnetic Resonance Imaging, Diffusion Tensor Imaging

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Multimodal MRI-guided rTMS

Arm Type

Experimental

Arm Title

Conventional T3-P3 rTMS

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

MagPro X100 repetitive Transcranial Magnetic Stimulation

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

MagPro X100 repetitive Transcranial Magnetic Stimulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Severity and Frequency of Hallucinations

Description

Visual Analogue Scale (Severity)/ Visual Analogue Scale (Frequency rate)

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)

Secondary Outcome Measure Information:

Title

Clinical State

Description

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)

Title

MRI changes

Description

structural MRI/ functional MRI/ Diffusion Tensor Imaging/ MR-spectroscopy

Time Frame

Assessed at baseline (t0) and 1 month after the rTMS sessions (M+1)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Renaud Jardri, M.D., Ph.D.

Organizational Affiliation

Lille University Medical Centre, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lille University Hospital Centre

City

Lille

ZIP/Postal Code

F-59037

Country

France

Facility Name

Saint-Anne Psychiatric Hospital

City

Paris

ZIP/Postal Code

75005

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28660668

Citation

Leroy A, Foucher JR, Pins D, Delmaire C, Thomas P, Roser MM, Lefebvre S, Amad A, Fovet T, Jaafari N, Jardri R. fMRI capture of auditory hallucinations: Validation of the two-steps method. Hum Brain Mapp. 2017 Oct;38(10):4966-4979. doi: 10.1002/hbm.23707. Epub 2017 Jun 28.

Results Reference

derived

Learn more about this trial

Multimodal MRI-guided rTMS to Treat Refractory Hallucinations

We'll reach out to this number within 24 hrs