SubGenual CG25 Deep Brain Stimulation in Severe Resistant Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      Despite the availability of several treatments, a number of patients with major depression
      are refractory to therapeutical approaches and therefore suffer from chronic handicap. For
      these severe patients, neurosurgical therapies can be envisaged. They aim at interrupting
      bundles that link the orbitofrontal cortex with striatum and can therefore benefit for the
      patients.

      This study intends to repeat Dr. Lozano's study, published in 2005 in the journal Neuron. In
      this study, they performed a preliminary evaluation of chronic deep brain stimulation (DBS)
      of the subgenual cingulate region (Brodmann area 25) to treat refractory depression as an
      alternative to subcaudate tractotomy. This last technique was employed in Grenoble in the 60s
      with satisfying results before neurosurgery for psychiatric disorders was abandoned. Since
      1992, psychosurgical therapies that respect ethical recommendations have regained interest to
      treat highly impaired patients. Before the investigators can propose deep brain stimulation
      of subgenual cingulate brain region as a new therapeutic approach for the investigators
      patients in Grenoble, the investigators decided to reproduce their clinical evaluation on a
      group of 6 patients, repeating their methodology faithfully. Therefore nothing was changed to
      the model used by Drs. Lozano and Mayberg and the investigators took advantage of the
      investigators own expertise regarding deep brain stimulation and subcaudate tractotomy.

      Protocol is strictly identical to the one of Mayberg and Lozano in order to confirm their
      preliminary results. Cartography of physiological consequences of this procedure will be
      assessed by measuring cerebral blood flow by PET scan (positron emission tomography).
      Patients will be monitored and thoroughly assessed during including psychiatric,
      neurological, neurosurgical, neuropsychological and PET scan exams to measure treatment
      efficacy and potential adverse reactions. Patients will be followed for two more years to
      assess medium-term complications. This study will be a first step toward further research
      including potentially a multicentric clinical trial.
    

Detailed description: 
      The protocol involves assessment of effects of CG25 (subgenual cingulate area-Brodmann 25)
      DBS on mood, anxiety, apathy, anhedonia, psychomotor retardation, functional state as well as
      safety and tolerance by specific psychometric scores.

      Moreover the protocol aims at highlighting the neurocircuits modulated by CG25 DBS by means
      of PET (positron emission tomography) imagery
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients suffering from severe depression and referred by the psychiatry department of
        french University Hospital
      
Keywords: deep brain stimulation; subgenual cortex (CG25)