Title

Deep brain stimulation in refractory schizophrenia: a combined open/double-blind crossover trial of the nucleus accumbens and ventral tegmental area as therapeutic targets

Objective

Deep brain stimulation (DBS) delivers high-frequency electrical pulses to specific brain areas through implanted electrodes. L'ECP has an established place in certain neurological disorders and has also shown encouraging results in refractory forms of obsessive-compulsive disorders and depression. Despite the growing interest in studying its usefulness for patients with resistant schizophrenia, the evidence is preliminary. A single previous trial (n=7), carried out in part by members of the current research group, found preliminary evidence of efficacy in patients with treatment-resistant schizophrenia by stimulating the nucleus accumbens, a dopamine-rich brain region.

The present study aims to further examine the efficacy and safety of ECP in the nucleus accumbens (n=4) and to explore potential efficacy in a new area, the ventral tegmental area (n=4), a brain region d' where relevant dopaminergic projections appear in schizophrenia. The study will follow the design of l 'previous trial: after an open phase d 'stabilization of 6 months (or more), the patients who meet certain improvement criteria will access a crossover phase of 12 weeks under double-blind conditions where the current will be turned off for half the time. An extension phase (more than 12 months) will control long-term adverse psychiatric effects.