Phase 1 Study of Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia
Deep Brain Stimulation(DBS)
+ Capsulotomy
Signes et symptômes digestifs+1
+ Conditions pathologiques, signes et symptômes
+ Anorexie
Étude thérapeutique
Résumé
Date de début de l'étude : 1 avril 2012
Date à laquelle le premier participant a commencé l'étude.Anorexia nervosa (AN) is a serious eating disorder mostly affecting adolescent girls and young adult women. Although the etiology of AN is still unclear, it is unanimous that social, genetic and psychological factors appear to be involved in the onset and maintenance of this disorder. There are many methods in the treatment of AN, such as family therapy, cognitive behavioral therapy, psychotherapy and so on. However, almost 50% of patients are refractory to all current medical treatment and never fully recover and the standardized mortality ratio over the first 10 years is about 10%. For treatment-refractory anorexia, stereotactic functional neurosurgery may be the better choice. Neurosurgery has been used in the treatment of mental diseases for more than fifty years. Deep brain stimulation and capsulotomy are the most used methods which has been proved effective in obsessive and compulsive disorders, depression and other psychiatric disorders. Many case reports indicate that deep brain stimulation or capsulotomy may be effective in the treatment of AN. As there are some common pathways between AN and other psychiatric disorders. The investigators have a hypothesis that deep brain stimulation and capsulotomy may be promising methods in the treatment of AN.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.48 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 60 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: The age was between 18 to 60 years old. Diagnosis of Anorexia Nervosa by the Diagnostic and Statistical Manual (DSM-IVR) Able to comply with all testing, follow-ups and study appointments and protocols. Treatment Resistance is defined by some or all of: The duration of AN was more than 3 years and no period of good function. The disorder severely affected the quality of life of the patient, preventing participation in normal activities such as work or study. Chronic stable AN lasting at least 10 years. Exclusion Criteria: Patients with obviously encephalatrophy which was confirmed by MRI. Patients who were alcohol or substance dependence or abuse in the last 6 months. Patients who can not undergo the Magnetic Resonance Imaging (MRI) or Positron Emission Tomography (PET) scanning patients can not complete the 12 months follow-up. Patients with severe heart diseases or other organic problem who could not undergo the neurosurgery. Pregnancy -
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site