HallucinationsMULTIMODHALNCT01373866
Multimodal MRI-guided rTMS to Treat Refractory Hallucinations
A study testing MagPro X100 repetitive Transcranial Magnetic Stimulation in people with Hallucinations and Schizophrenia, run by University Hospital, Lille at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 60 years
- Conditions the study is for
- Hallucinations, Schizophrenia, Perceptual Disorders
- What is being tested?
- MagPro X100 repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Nov 2010to 11 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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,
Who cannot join
- Pregnancy
- Contraindication to MRI scan
- Contraindication to rTMS treatment
- Claustrophobia
- No social insurance
Trial locations and contacts
2 sites in 1 country.
France2 sites
Lille University Hospital Centre
Lille, F-59037
Saint-Anne Psychiatric Hospital
Paris, 75005
About this study
Official title: 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
- Conditions
- Hallucinations, Schizophrenia, Perceptual Disorders
- Being tested
- MagPro X100 repetitive Transcranial Magnetic Stimulation
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Neuronavigation, Functional Magnetic Resonance Imaging, Diffusion Tensor Imaging
- Medical subject headings
- Hallucinations, Schizophrenia, Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
MagPro X100 repetitive Transcranial Magnetic StimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Multimodal MRI-guided rTMS | Experimental | Not described Receives: Device: MagPro X100 repetitive Transcranial Magnetic Stimulation |
| Conventional T3-P3 rTMS | Active comparator | Not described Receives: Device: MagPro X100 repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity and Frequency of Hallucinations
Visual Analogue Scale (Severity)/ Visual Analogue Scale (Frequency rate)
Measured: 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
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]
Measured: 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
structural MRI/ functional MRI/ Diffusion Tensor Imaging/ MR-spectroscopy
Measured: Assessed at baseline (t0) and 1 month after the rTMS sessions (M+1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study start15 Nov 2010
- Primary completion11 Feb 2022
- Study completion11 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HallucinationsStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renaud Jardri, M.D., Ph.D., Principal investigator, Lille University Medical Centre, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373866
- Sponsor's protocol ID
- 2009_17/0927
- Other IDs
- 2009-A00842-55
- Acronym
- MULTIMODHAL
- Status last verified
- Dec 2025
- First submitted
- 13 May 2011
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 25733569Leroy 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal MRI-guided Repetitive Transcranial Magnetic Stimulation to Treat Drug-resistant Hallucinations: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01373866
- Acronym / sponsor ID
- MULTIMODHAL / 2009_17/0927
- Conditions
- Hallucinations, Schizophrenia, Perceptual Disorders
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Neuronavigation, Functional Magnetic Resonance Imaging, Diffusion Tensor Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 15 Nov 2010 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 11 Feb 2022 (actual)
- First posted
- 15 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 13 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (5 listed)
- Pregnancy
- Contraindication to MRI scan
- Contraindication to rTMS treatment
- Claustrophobia
- No social insurance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagPro X100 repetitive Transcranial Magnetic StimulationTarget 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 | Multimodal MRI-guided rTMS |
| MagPro X100 repetitive Transcranial Magnetic StimulationTarget: 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 | Device | Conventional T3-P3 rTMS |
Primary outcome
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)
2 secondary outcomes
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)
MRI changes
Time frame: Assessed at baseline (t0) and 1 month after the rTMS sessions (M+1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Results publication: PubMed 25733569Demeulemeester 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.
- Derived from this study: PubMed 28660668Leroy 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.
- Individual participant dataSharing planned: No
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DecNef for Auditory Verbal Hallucinations (AVH) in Schizophrenia
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Recruiting
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Schizophrenia, Auditory Verbal Hallucinations
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renaud Jardri, M.D., Ph.D. principal investigator
Lille University Medical Centre, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagPro X100 repetitive Transcranial Magnetic Stimulation in people with Hallucinations and Schizophrenia, run by University Hospital, Lille at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01373866, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.