REstoring CONsciousness With NEurostimulation of the Central Thalamus: The RECONNECT Study
Samuel Snider, MD
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.
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 th…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Central nervous system injury of any etiology (e.g., cardiac arrest, traumatic brain injury, ischemic stroke, cerebral hemorrhage, encephalitis) that occurred at least 3 months prior to the eligibility phone call * The participant does not exhibit either of the following behaviors every day: meaningful interaction (defined as intelligible speech and ability to follow verbal commands) or functional object use * A CRS-R based diagnosis of DoC; either Unresponsive Wakefulness Syndrome (UWS) or Minimally Conscious State (MCS- or +). * The participant must have a documented h…
Interventions
- DeviceDeep brain stimulation (DBS) electrode implantation
DBS electrodes implanted to two targets in each thalamus.
Location
- Brigham and Women's HospitalBoston, Massachusetts