NCT07315685: STAR

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

Not yet recruiting NA Last updated 2 January 2026

What this trial tests

NA trial testing neurostimulator in Autism Spectrum Disorder in 6 participants. Not yet recruiting.

Timeline

13 January 2026

Primary endpoint
8 October 2028

8 December 2028

Quick facts

Lead sponsor	University Hospital, Rouen
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	6
Start date	13 January 2026
Primary completion	8 October 2028
Estimated completion	8 December 2028

Drugs / interventions tested

• neurostimulator

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
• Schizophrenia Disorder — all drugs for Schizophrenia Disorder →

Sponsor

University Hospital, Rouen

Who can join

Adults 18 to 70, any sex, with Autism Spectrum Disorder or Schizophrenia Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.