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Autism Spectrum DisorderSTARNCT07315685

Understanding and Treating Severe and Resistant Pathological Aggression: Using Deep Brain Stimulation to Treat Resistant Aggression

A study testing neurostimulator in people with Autism Spectrum Disorder and Schizophrenia Disorder, run by University Hospital, Rouen at 2 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Physical aggression can be defined as the use of force with the intention of causing physical injury, psychological damage or death. Pathological aggression may be associated with various psychiatric disorders. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
neurostimulator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesFrance
Study dates
13 Jul 2026to 8 May 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged between 18 and 70 inclusive
  • Patients who have been in isolation in a secure psychiatric unit for at least 50% of the time over a period of more than 6 months prior to inclusion
  • A GAF score <21
  • An ICAP score <40
  • Other stable medical conditions
  • No contraindications to brain imaging (MRI and CT)
Show all 19Show fewer
  • No contraindications to taking medication for travel (loxapine and diazepam)
  • No contraindications to surgery
  • Adult who has read and understood the information letter and signed the consent form. A psychiatrist, independent of the study and treatment, will examine the patient and determine their ability to read and understand the consent form before signing. If this is not the case, authorisation may be given by the guardianship judge in accordance with Article L. 1111-6.
  • An adult assisted by their guardian or by the judge who has read and understood the information letter and signed the consent form (if the patient is under guardianship). If the guardian does not wish to give an opinion or make a decision for the patient, the guardianship judge may be consulted in accordance with Article L1223-1.
  • Patients covered by social health insurance (except AME)
  • Women of childbearing age (a woman is considered to be of childbearing age, i.e. fertile, after menarche and until she reaches menopause, unless she is permanently infertile) using at least minimally effective contraception (i.e. at least: oral progestogen-only contraception, where inhibition of ovulation is not the primary mode of action, male or female condoms with or without spermicide, diaphragm, diaphragm or sponge with spermicide) for at least 1 month and throughout the study, as well as a negative urinary pregnancy test for β-HCG at inclusion.
  • Surgically sterile women (hysterectomy, bilateral salpingectomy and bilateral oophorectomy)
  • Menopausal women: Post-menopausal status is defined as the absence of menstruation for 12 months without any other medical cause. Elevated follicle-stimulating hormone (FSH) levels in the post-menopausal interval may be used to confirm post-menopausal status in women who are not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of amenorrhoea, a single FSH measurement is insufficient.
  • For schizophrenic patients
  • All previous treatments have failed, including the combination of clozapine (for at least 6 months with clozapine levels > 350 ng/mL) + ECT (minimum 20 sessions)
  • Have had at least two clozapine potentiations among the following: lithium, valproic acid, beta-blockers, other antipsychotics.
  • For ASD patients with or without intellectual disability
  • All recommended psychoeducational measures must have been attempted with failure of the following treatments: risperidone, aripiprazole, clozapine, naltrexone, beta-blockers given for at least three months at the maximum tolerated dose.

Who cannot join

  • Minors
  • Contraindications to surgery and anaesthesia
  • Contraindications to the use of the Medical Device (diathermy, certain magnetic resonance imaging procedures, transcranial magnetic stimulation (TMS), (see section 'Contraindications' in the 'Information for Prescribers' manual for the implanted neurostimulator)
  • Contraindications to MRI and CT scans (cardiac or neural pacemakers, ferromagnetic surgical clips, implants and metallic objects, intraocular foreign bodies, pregnancy, claustrophobia, cardiac or neural pacemakers, ferromagnetic surgical clips, implants and metallic objects, intraocular foreign bodies, etc.)
  • Other medical problems interfering with the protocol and surgery
  • Pregnant women

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Carine Karachi, Pr contact

01 42 16 33 29

karine.martin@aphp.fr

France2 sites

  • Ap-Hp Pitie Salpetriere

    Paris

    Carine Karachi, Pr, 01 42 16 33 29, karine.martin@aphp.fr

    Carine Karachi, Pr

  • CH du ROUVRAY

    Rouvray, 76301

    Olivier Guillin, Pr, 02 32 95 10 30, olivier.guillin@ch-lerouvray.fr

    Olivier Guillin, Pr

Other trials in France

About this study

Physical aggression can be defined as the use of force with the intention of causing physical injury, psychological damage or death. Pathological aggression may be associated with various psychiatric disorders. This symptom can often be improved by prescribing medication, implementing psychoeducational strategies or even electroconvulsive therapy. However, some patients exhibit such severe pathological aggression that they must be institutionalised because they pose a danger to themselves or others. These patients are then hospitalised in a unit for difficult patients (UMD) for enhanced therapeutic care. Despite this maximum level of care, the pathological aggression of a minority of patients persists, leading to a therapeutic impasse, confining the patient to the UMD for many years with social isolation, a collapsed quality of life, and major repercussions for the family. The aim of this project is to use deep brain stimulation, a controlled, reversible, adaptable and low-morbidity neurosurgical method, in six patients with pathological aggression suffering from either schizophrenia (n=3) or autism spectrum disorders (n=3). We hypothesise that the effects of deep brain stimulation (DBS) of the Sano triangle will significantly control the pathological aggression of these six patients.

This is a pilot study with randomised, crossover, double-blind evaluation. It will also provide answers regarding the safety of using SCP for this indication.

Being tested
neurostimulator
Medical subject headings
Autism Spectrum Disorder, Schizophrenia

What participants receive

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

  • neurostimulatorDevice

    implantation of a neurostimulator and stimulation of the triangle of Sano by alternating ON and OFF phases

Study groups in NCT07315685
Study groupRoleWhat they receive
OFF (6-8) ON (8-10)ExperimentalGroup 1: stimulation turned off for 2 months (OFF-DBS from M6 to M8) and will be turned back on for 2 months (ON-DBS from M8 to M10).
Receives: Device: neurostimulator
ON (6-8) OFF (8-10)ExperimentalGroup 2: stimulation switched on for 2 months (ON-DBS from M6 to M8) and switched off for 2 months (OFF-DBS from M8 to M10).
Receives: Device: neurostimulator
ON (6-7) OFF (7-9) ON (9-10)ExperimentalGroup 3: stimulation switched on for 1 month (ON-DBS from M6 to M7), switched off for 2 months (OFF-DBS from M7 to M9) then switched back on for 1 month (ON-DBS from M9 to M10).
Receives: Device: neurostimulator

What is being measured

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

  1. To evaluate the effects of SCP of the Sano triangle on pathological aggression quantified by the MOAS scale after 1 month of SCP compared to the preoperative state.

    Measured: 9 months

Secondary outcomes (8)

  1. The tolerance and safety of Sano triangle SCP for treating pathological aggression in these six patients, with the collection of potential adverse events,

    Measured: 10 months

  2. The evaluation of the effects of Sano triangle SCP on pathological behaviours (ICAP scores up to M10),

    Measured: 10 months

  3. Assessment of the effects of Sano triangle SCP on the number of daily aggressive episodes up to M10 + 1 week,

    Measured: 10 months

  4. Assessment of the effects of Sano triangle SCP on quality of life (SF-36) up to M10,

    Measured: 10 months

  5. Assessment of the effects of Sano triangle SCP on socio-familial impact (GAF improved by 20% up to M10),

    Measured: 10 months

  6. Assessment of the effects of Sano triangle SCP on cognitive and mnemonic impact (TNI-93 up to M10),

    Measured: 10 months

  7. Study of changes in neuronal activity in local potential fields of the Sano triangle during aggressive episodes up to M10,

    Measured: 10 months

  8. Anatomical and diffusion MRI study for tractography analysis of fibre bundles in these patients, and study of the volume of activated tissue in relation to the effects observed.

    Measured: 10 months

Timeline

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

  1. First posted2 Jan 2026
  2. Study start13 Jul 2026 (estimated)
  3. Primary completion8 Apr 2029 (estimated)
  4. Study completion8 May 2029 (estimated)

Resources

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, Investigator, Outcomes assessor
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07315685
Sponsor's protocol ID
2023/0207/HP
Other IDs
2025-A00335-44
Acronym
STAR
Status last verified
Jun 2026
First submitted
18 Dec 2025
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing neurostimulator in people with Autism Spectrum Disorder and Schizophrenia Disorder, run by University Hospital, Rouen 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 19 inclusion and 6 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: opening soon, as of the sponsor's last update on 8 Jun 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carine Karachi, Pr (01 42 16 33 29, karine.martin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the effects of SCP of the Sano triangle on pathological aggression quantified by the MOAS scale after 1 month of SCP compared to the preoperative state. (time frame: 9 months). 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 NCT07315685.

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 8 Jun 2026; AzTrials last refreshed its copy on 28 Oct 2026.

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