SchizophreniaStim-TISiTBSNCT06142422

Intermittent Theta Burst Stimulation of the Precuneus

A study testing stimulation device in people with Schizophrenia, run by GCS Ramsay Santé pour l'Enseignement et la Recherche.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The purpose of the study is to compare the effectiveness of stimulation of the left precuneus by intermittent Theta Burst Stimulation to placebo stimulation on the severity of schizophrenia symptoms. Read more about this study

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Schizophrenia
What is being tested?: stimulation device
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: Jan 2026to Jun 2026
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 18 to 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Right-handed patient aged 18 to 40 years inclusive;
Patient presenting schizophrenia as defined in the Diagnostic and Statistical Manual-5;
Patient under antipsychotic treatment in accordance with the recommendations of the High Authority of Health, at a stable dosage and without modification of psychotherapeutic treatment for at least 4 weeks;
Patient on mono or dual antipsychotic therapy.
Patient presenting residual symptoms, i.e. absence of remission defined by the criteria of the "Remission criteria of the Schizophrenia Working Group Consensus";
Patient having been exposed to at least one type of trauma in childhood and having a score higher than the threshold values of the childhood trauma questionnaire: emotional neglect, physical abuse, emotional abuse, physical neglect, sexual abuse;
Patient having signed an informed consent form to participate in the study.

Who cannot join

Patient with a contraindication to magnetic resonance imaging or intermittent Theta Burst Stimulation (presence of a metallic body, pacemaker, implantable defibrillator or other implantable metallic device, epilepsy, stroke or recent head trauma);
Patient who is not French-speaking or cannot read and write;
Patient under guardianship;
Patient in forced care (psychiatric care upon decision of the State representative and psychiatric care at the request of a third party);
Pregnant woman or likely to be pregnant (of childbearing age) without effective contraception or breastfeeding;
Patient participating in another clinical trial, or during a period of exclusion from another clinical trial;
Patient who is not a beneficiary of a social security system.
Patient who, according to the assessment of the investigator, risks not being compliant or diligent in the study procedures.

About this study

Official title: Intermittent Theta Burst Stimulation of the Precuneus for the Treatment of Resistant Schizophrenia

The purpose of the study is to compare the effectiveness of stimulation of the left precuneus by intermittent Theta Burst Stimulation to placebo stimulation on the severity of schizophrenia symptoms.

Read the detailed description

This is an interventional, prospective, randomized, double-blind, multicenter study, comparing iTBS treatment (experimental group) of the precuneus to placebo stimulation (control group) of patients suffering from resistant schizophrenia and having been exposed to childhood trauma.

The study population will be patients aged 18 to 40 years old exposed to childhood trauma, presenting with schizophrenia resistant to antipsychotic treatments.

This study will be implemented in 4 investigative centers. Each patient will participate for a period of 3 months.

Conditions: Schizophrenia
Being tested: stimulation device
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

stimulation deviceProcedure or surgery
The procedure under study is the use of a stimulation device to perform treatment on the precuneus to treat resistant schizophrenia in patients exposed to childhood trauma.
The target is the left precuneus, which is defined by neuronavigation.

Study groups in NCT06142422
Study group	Role	What they receive
experimental group with intermittent Theta Burst Stimulation	Experimental	The procedure under study is the use of a stimulation device to perform intermittent Theta Burst Stimulation treatment on the precuneus to treat resistant schizophrenia. Targeting requires a neuronavigation device. Receives: Procedure: stimulation device
control group with placebo stimulation	Placebo comparator	In the control group, stimulation is simulated using a "Sham" or placebo coil. The stimulation device is the same as for the experimental group, only the coil differs. Receives: Procedure: stimulation device

What is being measured

The primary outcome is the main question the study is designed to answer.

average of the Scale for assessment of negative symptoms/scale for assessment of positive symptoms scale scores
The Primary Outcome Measure will be assessed by the average of the Scale for assessment of negative symptoms/scale for assessment of positive symptoms scale scores at approximately 21 days compared to the score at inclusion in the two groups.
Measured: 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2026Jun 2026

First posted21 Nov 2023
Study startJan 2026 (estimated)
Primary completionJun 2026 (estimated)
Study completionJun 2026 (estimated)

Why it stopped: The sponsor decided to terminate the study early on April 21, 2026. No patients were enrolled in this study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
Model description: interventional, prospective, randomized, double-blind, multicenter study
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06142422
Sponsor's protocol ID: 2023-A01006-39
Acronym: Stim-TISiTBS
Status last verified: Apr 2026
First submitted: 16 Nov 2023
Last updated: 4 May 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intermittent Theta Burst Stimulation of the Precuneus for the Treatment of Resistant Schizophrenia
ClinicalTrials.gov ID: NCT06142422
Acronym / sponsor ID: Stim-TISiTBS / 2023-A01006-39
Conditions: Schizophrenia
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The sponsor decided to terminate the study early on April 21, 2026. No patients were enrolled in this study.
Enrolment: 0 participants (actual)
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
Collaborators: Euraxi Pharma
Study start: Jan 2026 (estimated)
Primary completion: Jun 2026 (estimated)
Study completion: Jun 2026 (estimated)
First posted: 21 Nov 2023 (actual)
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 purpose of the study is to compare the effectiveness of stimulation of the left precuneus by intermittent Theta Burst Stimulation to placebo stimulation on the severity of schizophrenia symptoms.

Detailed description

The study population will be patients aged 18 to 40 years old exposed to childhood trauma, presenting with schizophrenia resistant to antipsychotic treatments.

This study will be implemented in 4 investigative centers. Each patient will participate for a period of 3 months.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: interventional, prospective, randomized, double-blind, multicenter study

Arm	Type	Receives
experimental group with intermittent Theta Burst Stimulation	Experimental	Procedure: stimulation deviceThe procedure under study is the use of a stimulation device to perform intermittent Theta Burst Stimulation treatment on the precuneus to treat resistant schizophrenia. Targeting requires a neuronavigation device.
control group with placebo stimulation	Placebo comparator	Procedure: stimulation deviceIn the control group, stimulation is simulated using a "Sham" or placebo coil. The stimulation device is the same as for the experimental group, only the coil differs.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Right-handed patient aged 18 to 40 years inclusive;
Patient presenting schizophrenia as defined in the Diagnostic and Statistical Manual-5;
Patient under antipsychotic treatment in accordance with the recommendations of the High Authority of Health, at a stable dosage and without modification of psychotherapeutic treatment for at least 4 weeks;
Patient on mono or dual antipsychotic therapy.
Patient presenting residual symptoms, i.e. absence of remission defined by the criteria of the "Remission criteria of the Schizophrenia Working Group Consensus";

Key exclusion criteria (8 listed)

Patient with a contraindication to magnetic resonance imaging or intermittent Theta Burst Stimulation (presence of a metallic body, pacemaker, implantable defibrillator or other implantable metallic device, epilepsy, stroke or recent head trauma);
Patient who is not French-speaking or cannot read and write;
Patient under guardianship;
Patient in forced care (psychiatric care upon decision of the State representative and psychiatric care at the request of a third party);
Pregnant woman or likely to be pregnant (of childbearing age) without effective contraception or breastfeeding;

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
stimulation deviceThe procedure under study is the use of a stimulation device to perform treatment on the precuneus to treat resistant schizophrenia in patients exposed to childhood trauma. The target is the left precuneus, which is defined by neuronavigation.	Procedure or surgery	control group with placebo stimulation, experimental group with intermittent Theta Burst Stimulation

Primary outcome

average of the Scale for assessment of negative symptoms/scale for assessment of positive symptoms scale scores
Time frame: 21 days
The Primary Outcome Measure will be assessed by the average of the Scale for assessment of negative symptoms/scale for assessment of positive symptoms scale scores at approximately 21 days compared to the score at inclusion in the two groups.

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing stimulation device in people with Schizophrenia, run by GCS Ramsay Santé pour l'Enseignement et la Recherche.

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 7 inclusion and 8 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: withdrawn, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.

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?

average of the Scale for assessment of negative symptoms/scale for assessment of positive symptoms scale scores (time frame: 21 days). 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 NCT06142422.

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 4 May 2026.