REstoring CONsciousness With NEurostimulation of the Central Thalamus: The RECONNECT Study
Start Date
11/1/2025
Completion Date
2/10/2029
Summary
The RE-CONNECT study is an early feasibility study to establish the safety, feasibility, and efficacy of two central thalamic deep brain stimulation targets in patients with chronic disorders of consciousness.
Detailed Description
The overall goal is to collect pilot data on the safety, feasibility, and comparative behavioral efficacy of DBS to two specific thalamic targets in patients with disorders of consciousness (DoC): A sub-region of the centromedian/parafascicular nucleus (CM-Pf) and the centrolateral nucleus (CL). The investigators will recruit 2 participants over two years to participate in a single-center, double-blinded, cross-over study. After consent, the investigators will first confirm the stability of the clinical DoC diagnosis during a 1-month screening period. The purpose of this phase is to ensure that participants are not already on a trajectory of clinical improvement. Investigators will then implant two DBS electrodes (PerceptTM; Medtronic) into each thalamus, one targeting the thalamic CM-Pf sub-region and the other targeting the CL nucleus. After a one-month recovery period, investigators will titrate stimulation settings, and participants will then enter a 10-month blinded stimulation phase comprising periods of either continuous daily real (STIM-ON) or sham (STIM-OFF) stimulation delivered separately to each target. One participant will receive CM-Pf stimulation blocks first and CL stimulation blocks second; the other participant will receive the reverse target order (CL then CM-Pf). Investigators will enroll two patients, measuring procedure and device-related adverse and serious adverse events, as well as the feasibility of successfully targeting the CM-Pf sub-region. Finally, investigators will measure and compare the magnitude of CM-Pf versus CL stimulation induced changes on a standardized behavioral scale for evaluating patients with DoC.
Eligibility Criteria
Age Range: 18 years to 55 years
Interventions
Deep brain stimulation (DBS) electrode implantation
Conditions
Locations
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States