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RECONNECT Study: Deep Brain Stimulation for Disorders of Consciousness

The RECONNECT study is exploring a treatment called deep brain stimulation (DBS) for people with long-term disorders of consciousness (DoC). This study will implant special electrodes into two areas of the brain's thalamus (a part of the brain that relays sensory and motor signals). Researchers want to see if stimulating these areas can help improve consciousness. They are looking for two participants, aged 18 to 55, who have had a brain injury at least three months ago and do not consistently show meaningful interaction. Success will be measured by changes in a scale called the Coma Recovery Scale Revised (CRS-R) over a 12-month period. The study's current status is unclear.

Study design
This is a single-center, double-blinded, cross-over study involving 2 participants. This means neither you nor the researchers will know when the stimulation is active or inactive, and you will experience both types of stimulation.
What's involved
You would first have a 1-month screening period. Then, you would undergo surgery to implant DBS electrodes, followed by a 1-month recovery. After that, there will be a 10-month period of stimulation, with outcomes assessed weekly during the 12-month study period.
Compensation
Not stated in the trial record.
Follow-up
Outcomes will be assessed weekly during the 12-month study period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07228286

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

Recruiting
EARLY_PHASE1Ages 18–55InterventionalDevice feasibility
Samuel Snider, MD
~2 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Deep brain stimulation (DBS) electrode implantation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Coma Recovery Scale Revised (CRS-R)
Measured over Outcomes will be assessed at baseline and weekly during the 12 month study period.

Conditions

Disorders of Consciousness

Explore related trials

Consciousness DisordersInjury of central nervous systemMinimally conscious stateUnresponsive Wakefulness Syndrome

NCT07228286

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Brigham and Women's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Samuel B Snider, MD
[email protected]
857-307-2391
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

\- 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

What this trial measures

  • Coma Recovery Scale Revised (CRS-R)Outcomes will be assessed at baseline and weekly during the 12 month study period.

    Behavioral scale for patients wth DoC. Range: 0 to 23 with higher values indicating greater levels of awareness.