Understanding and Treating Severe and Resistant Pathological Aggression: Using Deep Brain Stimula… (NCT07315685) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Understanding and Treating Severe and Resistant Pathological Aggression: Using Deep Brain Stimulation to Treat Resistant Aggression
France6 participantsStarted 2026-07-13
Plain-language 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. 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
* 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 inhibi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.