Evaluation of the Functional Results of Bilateral Amygdalotomy for Refractory Aggressive Patients

NCT03452878 | Active Not Recruiting DMC

• 1 other identifier: 2014-63
• Study Type: observational
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aggressiveness has a high prevalence in the psychiatry population and is of major concern. Though pharmacological treatments are effective for most patients, there is a portion that doesn't respond properly and is considered medically refractory. For them, surgical procedures (i.e. stereotactic lesions) have been performed as an attempt to reintegrate patient into society. The amygdala is a main structure in the control of aggressive behavior and amygdala lesion could improve behavior without neurological or other behavioral impairment. In this study, it will evaluate the functional results of the bilateral amygdala lesion of aggressive refractory patients through neuroimaging, clinical assessment and blood hormonal levels. To better understand the neurobiology of aggression, aggressive patients that are not refractory will also be studied through neuroimaging and hormonal levels.

Conditions

Aggression

Keywords

Amygdala, neurosurgery, aggressive behavior

Outcome Measures

Primary Outcomes (1)

• Change in Aggression Levels

  The level of aggression of the patients will be assessed using the overt aggression scale (OAS)

  48 months

Secondary Outcomes (2)

• Change in quality of life

  48 months

• Follow-up hormones

  48 months

Study Arms (1)

Aggressive refractory patient

A pre defined group of individuals will be included in the study. This group is considered aggressive refractory patient and will be submitted to the bilateral amygdalotomy surgery.

Behavioral: Aggressive behavior

Interventions

Aggressive behavior BEHAVIORAL

Aggressive Behavior Scale, Quality of Life (SF-36) and Agitated Behavior Scale, measurement of thyroid-stimulating hormone (TSH), T4, T3, Cortisol, Luteinizing Hormone (LH), Estradiol, Prolactin, Progesterone, testosterone, and sex hormone-binding globulin (SHBG) and Resonance Magnetic Imaging.

Aggressive refractory patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Refractory aggressive patients.

You may qualify if:

• Refractory aggression (Adler et al., 2015) defined by extreme levels of aggression after the use of Risperidone or Aripiprazole ou combination of others psychoactive drugs.

You may not qualify if:

• Patients with anatomical alterations that may disrupt the surgery, infections or non-controlled diseases, treatment with other experimental drugs, pregnant women or during lactation, psychological or sociological conditions that will not permit the patient to be accompanied by the medical staff.

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected.

MeSH Terms

Conditions

Aggression

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Study Officials

• Luiz Fernando Reis, PhD

  Hospital Sirio-Libanes

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, PhD

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: March 2, 2018
• Study Start: August 6, 2014
• Primary Completion: June 30, 2018
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share