REstoring CONsciousness With NEurostimulation of the Central Thalamus: The RECONNECT Study (NCT07228286)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (14 items).
Location: Brigham and Women's Hospital — Boston, Massachusetts
Age range: 18 Years to 55 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Brigham and Women's Hospital — Boston, Massachusetts
📞 Contact the Study Coordinator
Phone: (857) 307-2391
Email: ssnider@bwh.harvard.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: One participant will receive CM-Pf stimulation blocks first and CL stimulation blocks second; the other participant will receive the reverse target order (CL then CM-Pf).
Explore by condition: All Disorders of Consciousness clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.