Restoring consciousness using deep brain stimulation of the central thalamus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transcutaneous auricular vagus nerve stimulation to help regain consciousness after surgery for brain hemorrhage

  This study tests whether a noninvasive ear-based nerve stimulation can help adults recover consciousness after brain hemorrhage surgery.

  Recruiting Beijing Tiantan Hospital · Beijing · NCT07761507

• Focusing ultrasound to the central thalamus to help people with disorders of consciousness

  This study tests whether two sessions of low-intensity focused ultrasound can safely help people with severe brain injuries see if they become more awake or responsive.

  Recruiting Sunnybrook Health Sciences Centre · Toronto, Ontario · NCT07694258

• Recovery after coma from serious brain injury or illness

  This observational study will follow adults who are unconscious due to a serious brain illness or injury to see what medical, neurological, psychological, and social factors are linked with recovery over time.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07614074

• Theta-burst temporal interference stimulation to improve awareness in people with disorders of consciousness

  This study will test whether theta-burst patterned temporal interference stimulation (tTIs) can help adults with recent disorders of consciousness (vegetative or minimally conscious) show more signs of awareness.

  Recruiting Zhujiang Hospital · Guangzhou, Guangdong · NCT07539740

• Can a bedside brain scan (fNIRS) detect activity in healthy people and in people with disorders of consciousness

  This observational study tests whether functional near-infrared spectroscopy (fNIRS) can measure brain activity at the bedside in healthy adults and in patients with disorders of consciousness in the Neuro-ICU.

  Recruiting University of California, Los Angeles · Los Angeles, California · NCT07485361

• Transcutaneous auricular vagus nerve stimulation for people with disorders of consciousness

  This test tries transcutaneous auricular vagus nerve stimulation (taVNS) to see if it helps adults who are in a vegetative state or a minimally conscious state.

  Recruiting Zhujiang Hospital · Guangzhou, Guangdong · NCT07284732

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.