ClinicalTrials.gg
CompletedNCT01373866MULTIMODHALUpdated Dec 26, 2025

Multimodal MRI-guided rTMS to Treat Refractory Hallucinations

An interventional study of MagPro X100 repetitive Transcranial Magnetic Stimulation and MagPro X100 repetitive Transcranial Magnetic Stimulation in Hallucinations, Schizophrenia and Perceptual Disorders, sponsored by University Hospital, Lille. Completed at 2 sites in France. Open to participants aged 13 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-26.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Nov 2010, registered May 2011).
Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Randomized
Ages
13 Years to 60 Years
Sex
All
01

Study 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
02

Conditions studied

  • Hallucinations
  • Schizophrenia
  • Perceptual Disorders

Keywords

  • Repetitive Transcranial Magnetic Stimulation
  • Neuronavigation
  • Functional Magnetic Resonance Imaging
  • Diffusion Tensor Imaging
03

In context

Hallucinations

136 studies on the registry are indexed under Hallucinations; 35 are open to participants now.

This study's enrollment of 85 is above the median of 48 across 118 interventional studies indexed under Hallucinations.

Browse Hallucinations studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Right-handed Female/Male, [13-60 y.o.],
  • Schizophrenia ( 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

Exclusion Criteria:

  • Pregnancy
  • to MRI scan
  • Contraindication to rTMS treatment
  • Claustrophobia
  • No social insurance
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
85 participants (actual)

Study arms

  • Experimental
    Multimodal MRI-guided rTMS

    Device: MagPro X100 repetitive Transcranial Magnetic Stimulation

  • Active comparator
    Conventional T3-P3 rTMS

    Device: MagPro X100 repetitive Transcranial Magnetic Stimulation

Interventions

  • DeviceMagPro 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

  • DeviceMagPro 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

06

What researchers measure

Primary outcomes

  1. Severity and Frequency of Hallucinations

    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 outcomes

  1. 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 \[cbSASH\]

    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)

  2. MRI changes

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

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

07

Study locations

2 sites
  • Lille University Hospital Centre
    Lille, F-59037, France
  • Saint-Anne Psychiatric Hospital
    Paris, 75005, France
08

References and documents

Publications

  • 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. PubMed 25733569 ↗
  • 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. PubMed 28660668 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2010 to primary completion in Feb 2022, 134 months.

Of 53 non-industry interventional studies with no phase under Hallucinations, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 56. This study's 134 months is above that.

Counting every sponsor, half of 53 studies reached it within 37 months; a quarter within 20 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
May 13, 2011
First posted
Jun 15, 2011
StartActual
Nov 15, 2010
Primary completionActual
Feb 11, 2022
CompletionActual
Feb 11, 2022
Last update
Dec 26, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01373866
Responsible party
Sponsor
First posted
Jun 15, 2011
Start date
Nov 15, 2010
Primary completion
Feb 11, 2022
Completion
Feb 11, 2022
Last update
Dec 26, 2025

Study contacts

Renaud Jardri, M.D., Ph.D.
principal investigator · Lille University Medical Centre, France

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion