Early Phase 1 Study Evaluating Deep Brain Stimulation of Two Central Thalamic Areas to Restore Consciousness in Adults with Chronic Disorders of Consciousness

What this Trial Is About

Researchers are evaluating the safety, feasibility, and behavioral effects of deep brain stimulation DBS targeting two specific areas in the central thalamus for adults with chronic disorders of consciousness DoC. This early phase 1 study focuses on patients who have a stable diagnosis of DoC, such as Unresponsive Wakefulness Syndrome or Minimally Conscious State, aiming to compare stimulation effects between two thalamic regions the centromedianparafascicular sub-region and the centrolateral nucleus. Participants will undergo implantation of DBS electrodes in both thalamic targets. After a one-month recovery, stimulation settings will be adjusted, followed by a 10-month blinded phase where participants receive alternating periods of active stimulation or no stimulation sham targeting each thalamic area. The study uses a cross-over design with two participants, each receiving stimulation in a different order to compare effects between the two targets. Throughout the study, participants will be closely monitored with weekly assessments using the Coma Recovery Scale Revised CRS-R to evaluate changes in consciousness. Safety and device-related adverse events will be recorded, and the feasibility of targeting the specific thalamic sub-region will be assessed. The total study duration includes a 1-month screening period, 1-month recovery after implantation, and 10 months of blinded stimulation periods, with ongoing behavioral evaluations during the 12-month study timeline.

REstoring CONsciousness With NEurostimulation of the Central Thalamus: The RECONNECT Study