Actively Recruiting

Early Phase 1
Age: 18Years - 55Years
All Genders
NCT07228286

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

Led by Samuel Snider, MD · Updated on 2025-11-14

2

Participants Needed

1

Research Sites

169 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Central nervous system injury of any cause that happened at least 3 months before the eligibility phone call
  • No daily meaningful interaction, defined as intelligible speech or ability to follow verbal commands
  • Diagnosis of disorder of consciousness based on CRS-R, either Unresponsive Wakefulness Syndrome or Minimally Conscious State
  • Having a documented health care proxy or court-appointed guardian
  • Neurologist and neurosurgeon agree that MRI or CT shows no bilateral subcortical injury preventing electrode placement
Not Eligible

You will not qualify if you...

  • Pregnant
  • Unable to have brain MRI
  • Living outside the Greater Boston metropolitan area due to transportation needs
  • Pre-existing psychiatric, neurological, or medical condition making surgery unsafe, such as neurodegenerative disorder or significant heart/lung disease
  • Structural problems with chest wall, neck, brain, or skull that make electrode placement unsafe
  • Neurologist and neurosurgeon agree that MRI or CT shows no bilateral diffuse injury to the basal ganglia
  • Medical contraindications to surgery including chronic infection, blood clotting problems, poorly controlled high blood pressure with cardiovascular disease
  • Participation in another drug, device, or biological trial within 90 days
  • Having a current implanted stimulation device like pacemaker or deep brain stimulator
  • Taking anticoagulant or anti-platelet medication that cannot be stopped safely for more than 2.5 weeks around surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

S

Samuel B Snider, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

2

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