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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorSamuel Snider, MD

About this trial

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.

Eligibility criteria

Qualifiers

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 health care proxy or court-appointed guardian

Disqualifiers

- Pregnant

Contraindication to brain MRI

Due to transportation requirements, participants whose primary residence (Skilled Nursing Facility, Long Term Acute Care, or home) is outside the Greater Boston metropolitan area

Pre-existing psychiatric, neurological or medical condition that makes the patient, in the opinion of the study team, a poor surgical candidate (e.g., neurodegenerative disorder, significant cardiopulmonary disorder, need for chronic anticoagulation)

Trial design

Treatments tested in this trial

  • Deep brain stimulation (DBS) electrode implantation

Treatment groups

2 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Samuel Snider, MD

Lead sponsor

Brigham and Women's Hospital

Sponsor institution