Recruiting
Early Phase 1

Deep Brain Stimulation

Sponsor:

Samuel Snider, MD

Code:

NCT07228286

Conditions

Disorders of Consciousness

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Deep brain stimulation (DBS) electrode implantation

Study Details

Brief 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.

Conditions

Disorders of Consciousness

Study ID

NCT07228286

Start date

Nov 1, 2025

Status verified date

Jun, 2026

Completion date

Feb 10, 2029

Anticipated

Primary completion date

Feb 10, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • \- 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

Study Design

Enrollment

2 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: active stimulation

Each participant will receive a pre-determined sequence of active stimulation to one of two targets or no stimulation over the course of 10 months. This will be divided into two blocks (each with STIM and OFF periods) targeting each of the two thalamic targets. The order will be reversed in participant 2 relative to participant 1.

sham comparator: no stimulation

periods of no active stimulation intermixed with active stimulation to one of two targets.

Interventions

Deep brain stimulation (DBS) electrode implantation

DBS electrodes implanted to two targets in each thalamus.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Samuel B Snider, MD

857-307-2391ssnider@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Samuel Snider

8573072391ssnider@bwh.harvard.edu

More Information

Sponsor

Samuel Snider, MD

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • deep brain stimulation
  • disorders of consciousness
  • brain injury
  • thalamus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Samuel Snider, MD on 2026-06-23.