Study: PROSPECT, Northstar Neuroscience's investigation of implanted prefrontal cortical stimulation for treatment-resistant depression. 12

Design and measurements: This phase I feasibility protocol proposed an implanted stimulation system with a sham comparison. The record lists 12 anticipated participants. Unlike noninvasive repetitive transcranial magnetic stimulation, this approach involves surgically implanted equipment and therefore a materially different intervention and risk profile. 12

What is established: The historical record is terminated, with a December 2009 update. No verified response rate, remission rate, or adverse-event estimate was established from the inspected sources. The status does not by itself reveal why the study ended, and the proposed biological rationale should not be rewritten as demonstrated antidepressant benefit. 12