RecruitingEarly Phase 1NCT07228286

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

Sponsor

Samuel Snider, MD

Enrollment

2 participants

Start Date

Nov 10, 2025

Study Type

INTERVENTIONAL

Conditions

Disorders of Consciousness

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria5

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
Neurologist and neurosurgeon consensus review of most recent clinical MRI (if no MRI, then most recent CT) determines there is no bilateral subcortical injury preventing precise placement of electrodes (e.g., major injuries to the bilateral thalami or severe and bilateral subcortical anatomical distortions).

Exclusion Criteria13

\- 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)
Structural abnormality of the chest wall, neck, brain, or skull that makes safe placement of the electrodes, in the opinion of the study team, infeasible or prone to complication
Neurologist and neurosurgeon consensus review of most recent clinical MRI (if no MRI, then most recent CT) determines there is no bilateral diffuse injury to the basal ganglia
Medical contraindications to surgery including:
Chronic infection
Coagulopathy (INR \> 1.5, aPTT 45 sec, platelet count \< 100 x 103 / uL)
Poorly controlled blood pressure (\> 2 episodes during screening phase of blood pressure \> 180/110 sustained on repeated measurements) and evidence of cardiovascular disease
Participation in another drug, device or biological trial within 90 days
Current implanted stimulation device (e.g., pacemaker, defibrillator, spinal cord stimulator, deep brain stimulator)
Anticoagulant or anti-platelet medication that cannot be safely stopped for \> 2.5 weeks in the peri-operative period

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Interventions

DEVICEDeep brain stimulation (DBS) electrode implantation

DBS electrodes implanted to two targets in each thalamus.

Locations(1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

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NCT07228286

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