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

NCT07228286 | Recruiting Early Phase 1 DMC FDA Device

• 1 other identifier: 2025P001898
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Coma Recovery Scale Revised (CRS-R)

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

  Outcomes will be assessed at baseline and weekly during the 12 month study period.

Study Arms (2)

active stimulation

EXPERIMENTAL

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.

Device: Deep brain stimulation (DBS) electrode implantation

no stimulation

SHAM COMPARATOR

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

Device: Deep brain stimulation (DBS) electrode implantation

Interventions

Deep brain stimulation (DBS) electrode implantation DEVICE

DBS electrodes implanted to two targets in each thalamus.

active stimulation; no stimulation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Samuel Snider, MD: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders; Brain Injuries

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Samuel B Snider, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neurointensivist; Assistant Professor of Neurology Harvard Medical School

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 14, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): February 10, 2029
• Study Completion (Estimated): February 10, 2029
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (1)