NCT07228286

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 2 (estimated)
• Sponsor: Samuel Snider, MD · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Disorders of Consciousness

Interventions

Type	Name	Description
DEVICE	Deep brain stimulation (DBS) electrode implantation	DBS electrodes implanted to two targets in each thalamus.

Timeline

• Start date: 2025-11-10
• Primary completion: 2029-02-10
• Completion: 2029-02-10
• First posted: 2025-11-14
• Last updated: 2025-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study