Actively Recruiting
REstoring CONsciousness With NEurostimulation of the Central Thalamus: The RECONNECT Study
Led by Samuel Snider, MD · Updated on 2025-11-14
2
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying deep brain stimulation (DBS) targeting two specific areas in the central thalamus for patients with chronic disorders of consciousness (DoC), such as Unresponsive Wakefulness Syndrome or Minimally Conscious State. This early feasibility trial aims to collect initial data on the safety, feasibility, and behavioral effects of stimulating either the centromedian/parafascicular nucleus (CM-Pf) or the centrolateral nucleus (CL) in patients who have stable DoC diagnoses and no recent clinical improvement. The study is a double-blinded, cross-over design involving two participants to compare these two stimulation targets. The study involves implanting two DBS electrodes in each thalamus, one targeting the CM-Pf sub-region and the other targeting the CL nucleus. After a one-month recovery period, stimulation settings will be adjusted, followed by a 10-month blinded phase where participants receive alternating blocks of continuous daily real stimulation (STIM-ON) or sham stimulation (STIM-OFF) at each target. One participant will have the CM-Pf stimulation first and then CL; the other will have the reverse order. The researchers will monitor safety, adverse events, and the ability to target these brain regions precisely. Participants will be evaluated at baseline and weekly during the 12-month study period using the Coma Recovery Scale Revised (CRS-R) to assess behavioral changes. Clinical MRI or CT scans will be reviewed to confirm eligibility and electrode placement. The study also includes a 1-month screening phase to confirm diagnosis stability before implant surgery. Throughout the trial, researchers will track device-related effects, safety, and behavioral responses to stimulation to inform future treatment strategies for disorders of consciousness.
CONDITIONS
Brief Title
REstoring CONsciousness With NEurostimulation of the Central Thalamus: The RECONNECT Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Central nervous system injury of any cause occurring at least 3 months before screening
- No daily meaningful interaction or functional object use behaviors
- Diagnosis of disorder of consciousness (Unresponsive Wakefulness Syndrome or Minimally Conscious State) based on CRS-R
- Documented health care proxy or court-appointed guardian
- Neurologist and neurosurgeon review finds no bilateral subcortical injury preventing electrode placement
You will not qualify if you...
- Pregnant
- Contraindication to brain MRI
- Residence outside the Greater Boston metropolitan area
- Pre-existing psychiatric, neurological, or medical condition making surgery unsafe
- Structural abnormality of chest wall, neck, brain, or skull preventing safe electrode placement
- Bilateral diffuse injury to basal ganglia
- Chronic infection or coagulopathy
- Poorly controlled high blood pressure with cardiovascular disease
- Participation in another trial within 90 days
- Current implanted stimulation device
- Use of anticoagulant or anti-platelet medication that cannot be safely stopped for more than 2.5 weeks around surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 1 month
Participants are screened for eligibility to participate in the trial.
Visits to confirm the stability of clinical disorder of consciousness diagnosis
Duration - 1 day
Participants undergo implantation of two deep brain stimulation (DBS) electrodes targeting specific thalamic nuclei.
1 surgical implantation visit
Duration - 1 month
Participants have a recovery period after DBS electrode implantation.
Follow-up visits during recovery period
Duration - 10 months
Participants receive a 10-month blinded stimulation phase with alternating periods of active and sham stimulation to two different thalamic targets in a cross-over design.
Weekly visits for assessments during stimulation phases
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
S
Samuel B Snider, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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