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

Sponsor
University Hospital, Rouen
Study ID
NCT07315685
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jan 2, 2026
Start date
Jul 13, 2026
Status verified
Jun 2026
Primary completion
Apr 8, 2029
Completion
May 8, 2029

Study Design

Enrollment
6 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: OFF (6-8) ON (8-10)
    Group 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).
  • Experimental: ON (6-8) OFF (8-10)
    Group 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).
  • Experimental: ON (6-7) OFF (7-9) ON (9-10)
    Group 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).

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 ]

Central Contacts

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