Restoring consciousness using deep brain stimulation of the central thalamus
REstoring CONsciousness With NEurostimulation of the Central Thalamus: The RECONNECT Study
This trial will test whether deep brain stimulation of two specific central thalamus targets can help people with chronic disorders of consciousness become more responsive.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 2 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07228286 on ClinicalTrials.gov |
What this trial studies
RE-CONNECT is an early-phase, single-center, double-blinded crossover feasibility study enrolling two participants with chronic disorders of consciousness to compare DBS targeted to a CM-Pf sub-region and the centrolateral (CL) nucleus. After a one-month screening period to confirm diagnostic stability, participants will receive bilateral implantation of two DBS electrodes per thalamus, followed by a one-month recovery and stimulation titration period. Participants will then complete a 10-month blinded phase with alternating blocks of continuous real (STIM-ON) and sham (STIM-OFF) stimulation delivered separately to each target, with target order reversed between the two participants. Investigators will record procedural and device-related adverse events, feasibility of precise CM-Pf targeting, and comparative behavioral responses between the two stimulation targets.
Who should consider this trial
Good fit: Ideal candidates are adults at least three months after a central nervous system injury with a stable CRS-R diagnosis of Unresponsive Wakefulness Syndrome or Minimally Conscious State, who have a documented health care proxy or guardian and brain anatomy permitting safe electrode placement.
Not a fit: Patients with bilateral thalamic or severe subcortical damage that prevents accurate electrode placement, those who are rapidly improving, pregnant individuals, or those unable to undergo neurosurgery are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, targeted central thalamic stimulation could provide a new option to improve responsiveness and daily functioning for some patients with chronic disorders of consciousness.
How similar studies have performed: Small case series and uncontrolled reports have shown occasional behavioral gains with central thalamic DBS, but randomized or large controlled evidence is very limited and the approach remains experimental.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Samuel B Snider, MD
- Email: ssnider@bwh.harvard.edu
- Phone: 857-307-2391
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.