NCT01373866

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2022

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

11.2 years

First QC Date

May 13, 2011

Last Update Submit

December 18, 2025

Conditions

HallucinationsSchizophreniaPerceptual Disorders

Keywords

Repetitive Transcranial Magnetic StimulationNeuronavigationFunctional Magnetic Resonance ImagingDiffusion Tensor Imaging

Outcome Measures

Primary Outcomes (1)

  • Severity and Frequency of Hallucinations

    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 Outcomes (2)

  • Clinical State

    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

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

Study Arms (2)

Multimodal MRI-guided rTMS

EXPERIMENTAL
Device: MagPro X100 repetitive Transcranial Magnetic Stimulation

Conventional T3-P3 rTMS

ACTIVE COMPARATOR
Device: MagPro X100 repetitive Transcranial Magnetic Stimulation

Interventions

MagPro X100 repetitive Transcranial Magnetic StimulationDEVICE

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

Multimodal MRI-guided rTMS

Eligibility Criteria

Age13 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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,

You may not qualify if:

  • Pregnancy
  • Contraindication to MRI scan
  • Contraindication to rTMS treatment
  • Claustrophobia
  • No social insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lille University Hospital Centre

Lille, F-59037, France

Location

Saint-Anne Psychiatric Hospital

Paris, 75005, France

Location

Related Publications (2)

  • Demeulemeester M, Kochman F, Fligans B, Tabet AJ, Thomas P, Jardri R. Assessing early-onset hallucinations in the touch-screen generation. Br J Psychiatry. 2015 Mar;206(3):181-3. doi: 10.1192/bjp.bp.114.154153.

    PMID: 25733569RESULT

  • 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.

    PMID: 28660668DERIVED

MeSH Terms

Conditions

HallucinationsSchizophreniaPerceptual Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Renaud Jardri, M.D., Ph.D.

    Lille University Medical Centre, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2011

First Posted

June 15, 2011

Study Start

November 15, 2010

Primary Completion

February 11, 2022

Study Completion

February 11, 2022

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)