Disorders of ConsciousnessEarly Phase 1NCT07228286
REstoring CONsciousness With NEurostimulation of the Central Thalamus: The RECONNECT Study
A Early Phase 1 study testing Deep brain stimulation (DBS) electrode implantation in people with Disorders of Consciousness, run by Samuel Snider, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Disorders of Consciousness
- What is being tested?
- Deep brain stimulation (DBS) electrode implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 10 Feb 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- - 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Samuel Snider, 8573072391, ssnider@bwh.harvard.edu
About this study
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.
Read the detailed description
The overall goal is to collect pilot data on the safety, feasibility, and comparative behavioral efficacy of DBS to two specific thalamic targets in patients with disorders of consciousness (DoC): A sub-region of the centromedian/parafascicular nucleus (CM-Pf) and the centrolateral nucleus (CL). The investigators will recruit 2 participants over two years to participate in a single-center, double-blinded, cross-over study.
After consent, the investigators will first confirm the stability of the clinical DoC diagnosis during a 1-month screening period. The purpose of this phase is to ensure that participants are not already on a trajectory of clinical improvement. Investigators will then implant two DBS electrodes (PerceptTM; Medtronic) into each thalamus, one targeting the thalamic CM-Pf sub-region and the other targeting the CL nucleus. After a one-month recovery period, investigators will titrate stimulation settings, and participants will then enter a 10-month blinded stimulation phase comprising periods of either continuous daily real (STIM-ON) or sham (STIM-OFF) stimulation delivered separately to each target. 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). Investigators will enroll two patients, measuring procedure and device-related adverse and serious adverse events, as well as the feasibility of successfully targeting the CM-Pf sub-region. Finally, investigators will measure and compare the magnitude of CM-Pf versus CL stimulation induced changes on a standardized behavioral scale for evaluating patients with DoC.
- Conditions
- Disorders of Consciousness
- Being tested
- Deep brain stimulation (DBS) electrode implantation
- Keywords
- deep brain stimulation, disorders of consciousness, brain injury, thalamus
- Medical subject headings
- Consciousness Disorders, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulation (DBS) electrode implantationDevice
DBS electrodes implanted to two targets in each thalamus.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Deep brain stimulation (DBS) electrode implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coma Recovery Scale Revised (CRS-R)
Behavioral scale for patients wth DoC. Range: 0 to 23 with higher values indicating greater levels of awareness.
Measured: Outcomes will be assessed at baseline and weekly during the 12 month study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start1 Nov 2025
- Primary completion10 Feb 2029 (estimated)
- Study completion10 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samuel Snider, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samuel Snider, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228286
- Sponsor's protocol ID
- 2025P001898
- Status last verified
- Jun 2026
- First submitted
- 7 Nov 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REstoring CONsciousness With NEurostimulation of the Central Thalamus: The RECONNECT Study
- ClinicalTrials.gov ID
- NCT07228286
- Acronym / sponsor ID
- 2025P001898
- Conditions
- Disorders of Consciousness
- Keywords
- deep brain stimulation, disorders of consciousness, brain injury, thalamus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Samuel Snider, MDUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 10 Feb 2029 (estimated)
- Study completion
- 10 Feb 2029 (estimated)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall goal is to collect pilot data on the safety, feasibility, and comparative behavioral efficacy of DBS to two specific thalamic targets in patients with disorders of consciousness (DoC): A sub-region of the centromedian/parafascicular nucleus (CM-Pf) and the centrolateral nucleus (CL). The investigators will recruit 2 participants over two years to participate in a single-center, double-blinded, cross-over study.
After consent, the investigators will first confirm the stability of the clinical DoC diagnosis during a 1-month screening period. The purpose of this phase is to ensure that participants are not already on a trajectory of clinical improvement. Investigators will then implant two DBS electrodes (PerceptTM; Medtronic) into each thalamus, one targeting the thalamic CM-Pf sub-region and the other targeting the CL nucleus. After a one-month recovery period, investigators will titrate stimulation settings, and participants will then enter a 10-month blinded stimulation phase comprising periods of either continuous daily real (STIM-ON) or sham (STIM-OFF) stimulation delivered separately to each target. 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). Investigators will enroll two patients, measuring procedure and device-related adverse and serious adverse events, as well as the feasibility of successfully targeting the CM-Pf sub-region. Finally, investigators will measure and compare the magnitude of CM-Pf versus CL stimulation induced changes on a standardized behavioral scale for evaluating patients with DoC.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active stimulation | Experimental | Device: Deep brain stimulation (DBS) electrode implantationEach 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. |
| no stimulation | Sham comparator | Device: Deep brain stimulation (DBS) electrode implantationperiods of no active stimulation intermixed with active stimulation to one of two targets. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (13 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep brain stimulation (DBS) electrode implantationDBS electrodes implanted to two targets in each thalamus. | Device | active stimulation, no stimulation |
Primary outcome
Coma Recovery Scale Revised (CRS-R)
Time frame: Outcomes will be assessed at baseline and weekly during the 12 month study period.
Behavioral scale for patients wth DoC. Range: 0 to 23 with higher values indicating greater levels of awareness.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Deep brain stimulation (DBS) electrode implantation in people with Disorders of Consciousness, run by Samuel Snider, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel B Snider, MD (857-307-2391, ssnider@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coma Recovery Scale Revised (CRS-R) (time frame: Outcomes will be assessed at baseline and weekly during the 12 month study period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.