Depression Clinical Trial
Official title:
Subgenual Cingulate Stimulation in Resistant Depression
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.
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
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