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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Hospital, Rouen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • neurostimulator

    Device

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

Treatment groups

6 Participants
are divided into 3 treatment groups
Group A: OFF (6-8) ON (8-10)Experimental treatment 1 intervention
Group B: ON (6-8) OFF (8-10)Experimental treatment 1 intervention
Group C: ON (6-7) OFF (7-9) ON (9-10)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
9 months

Secondary outcomes

1

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
2

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

Time frame
10 months
3

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

Time frame
10 months
4

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

Time frame
10 months

Other outcomes

Sponsors and contacts

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University Hospital, Rouen

Lead sponsor

Centre Hospitalier du Rouvray

Collaborator

Groupe Hospitalier Pitie-Salpetriere

Collaborator

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