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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
6
implantation of a neurostimulator and stimulation of the triangle of Sano by alternating ON and OFF phases
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
The tolerance and safety of Sano triangle SCP for treating pathological aggression in these six patients, with the collection of potential adverse events,
Time frame: 10 months
The evaluation of the effects of Sano triangle SCP on pathological behaviours (ICAP scores up to M10),
Time frame: 10 months
Assessment of the effects of Sano triangle SCP on the number of daily aggressive episodes up to M10 + 1 week,
Time frame: 10 months
Assessment of the effects of Sano triangle SCP on quality of life (SF-36) up to M10,
Time frame: 10 months
Assessment of the effects of Sano triangle SCP on socio-familial impact (GAF improved by 20% up to M10),
Time frame: 10 months
Assessment of the effects of Sano triangle SCP on cognitive and mnemonic impact (TNI-93 up to M10),
Time frame: 10 months
Study of changes in neuronal activity in local potential fields of the Sano triangle during aggressive episodes up to M10,
Time frame: 10 months
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.
Time frame: 10 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.