Chronic Traumatic Brain InjuryNCT07730099
Cognitive Network Restoration Therapy for Moderate to Severe Traumatic Brain Injury: A Feasibility Study
A study testing Deep brain stimulation in people with Chronic Traumatic Brain Injury and TBI (Traumatic Brain Injury), run by ReEmerge, Inc..
Trial summary
The purpose of this feasibility clinical investigation is to evaluate the safety and usability of central thalamic deep brain stimulation (CT-DBS) for use in patients with chronic moderate to severe traumatic brain injury (TBI) and to explore its potential effects on cognitive and functional outcomes. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Chronic Traumatic Brain Injury, TBI (Traumatic Brain Injury)
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2027to Jan 2029
- Phase
- Interventional
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of moderate to severe TBI based on estimated worst Glasgow Coma Scale (GCS) score within first 48 hours of injury (acceptable GCS range = 3-12)
- Age ≥18 and <75 years at the time of informed consent.
- At least 24 months from date of TBI injury
- Fluent in local language and able to independently provide consent
- Rating of upper moderate disability to lower good recovery on the Glasgow Outcome Scale-Extended (GOSE) at time of enrollment (acceptable GOSE range 5-7)
- Failure to return to pre-injury level of vocational or educational function
- Either receiving no CNS stimulants or other medications known to affect cognitive function, or on stable doses of these medications for at least last three months prior to signing consent.
Who cannot join
- History of major developmental, neurologic, psychiatric or substance use disorder with evidence of disability prior to onset of TBI
- Any DSM-5 personality disorder diagnosis, as determined by SCID-5-PD, will exclude the participant.
- Major medical co-morbidities: end stage renal failure, heart failure, severe congestive heart disease, coagulopathy, severe respiratory problems, liver failure, uncontrolled hypertension or other significant medical co-morbidities.
- Receiving anti-epileptic medications to control active seizures
- Have had a documented seizure within 3 months prior to signing consent
- Malignancy with < 5 years life expectancy.
Show all 16Show fewer
- Untreated / uncontrolled (severe at the time of enrollment) depression or other psychiatric disorder.
- Women of childbearing age who do not regularly use an accepted contraceptive method. Participants who become pregnant after enrollment may be excluded from the study. Those who become pregnant prior to the surgical implantation of the DBS system will be excluded from the study.
- Inability to stop Coumadin or platelet anti-aggregation therapy before, during and after surgery.
- Previous DBS or other brain implants
- Previous ablative intracranial surgery
- Implantable hardware not compatible with MRI or unwilling to undergo MRI (e.g. claustrophobia)
- Condition requiring diathermy after DBS implantation
- Hardware, lesions or other factors limiting placement of electrodes in optimal target location in the judgment of the implanting surgeon
- Concurrent enrollment in any other clinical trial
- Any condition that, in the judgment of the PI, significantly increases risk or significantly reduces the likelihood of benefit from DBS
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this feasibility clinical investigation is to evaluate the safety and usability of central thalamic deep brain stimulation (CT-DBS) for use in patients with chronic moderate to severe traumatic brain injury (TBI) and to explore its potential effects on cognitive and functional outcomes.
- Being tested
- Deep brain stimulation
- Keywords
- Deep Brain Stimulation, DBS, TBI, Central thalamus
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationDevice
Also called CT-DBS, DBS
Delivery of continuous, low-voltage electrical pulses to deep portions of the brain via an implantable pacemaker-like device.
| Study group | Role | What they receive |
|---|---|---|
| CT-DBS | Experimental | Participants will be treated with deep brain stimulation throughout the study. Receives: Device: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device and Procedure Safety
Proportion of participants experiencing at least one device or procedure related serious adverse event (SAE) from implantation through Day 90 after stimulation activation, including events such as intracranial hemorrhage, infection requiring explant or IV antibiotics, lead or hardware complications requiring surgical intervention, or other SAEs judged related to the DBS system, implantation procedure, or stimulation therapy.
Measured: Implant through Day 90 after stimulation activation.
Secondary outcomes (1)
Overall Safety
Overall incidence of all adverse events (serious and non serious), summarized by MedDRA system organ class and preferred term, severity, and relationship to device/procedure from implantation through Day 90 after stimulation activation.
Measured: Implant through Day 90 after stimulation activation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study startFeb 2027 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Traumatic Brain InjuryStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReEmerge, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Fosdick, MS, Study director, ReEmerge, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730099
- Sponsor's protocol ID
- CNRT-001
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Network Restoration Therapy for Moderate to Severe Traumatic Brain Injury: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07730099
- Acronym / sponsor ID
- CNRT-001
- Keywords
- Deep Brain Stimulation, DBS, TBI, Central thalamus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- ReEmerge, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2027 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 28 Jul 2026 (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 purpose of this feasibility clinical investigation is to evaluate the safety and usability of central thalamic deep brain stimulation (CT-DBS) for use in patients with chronic moderate to severe traumatic brain injury (TBI) and to explore its potential effects on cognitive and functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT-DBS | Experimental | Device: Deep brain stimulationParticipants will be treated with deep brain stimulation throughout the study. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- History of moderate to severe TBI based on estimated worst Glasgow Coma Scale (GCS) score within first 48 hours of injury (acceptable GCS range = 3-12)
- Age ≥18 and <75 years at the time of informed consent.
- At least 24 months from date of TBI injury
- Fluent in local language and able to independently provide consent
- Rating of upper moderate disability to lower good recovery on the Glasgow Outcome Scale-Extended (GOSE) at time of enrollment (acceptable GOSE range 5-7)
Key exclusion criteria (16 listed)
- History of major developmental, neurologic, psychiatric or substance use disorder with evidence of disability prior to onset of TBI
- Any DSM-5 personality disorder diagnosis, as determined by SCID-5-PD, will exclude the participant.
- Major medical co-morbidities: end stage renal failure, heart failure, severe congestive heart disease, coagulopathy, severe respiratory problems, liver failure, uncontrolled hypertension or other significant medical co-morbidities.
- Receiving anti-epileptic medications to control active seizures
- Have had a documented seizure within 3 months prior to signing consent
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 stimulationAlso: CT-DBS, DBSDelivery of continuous, low-voltage electrical pulses to deep portions of the brain via an implantable pacemaker-like device. | Device | CT-DBS |
Primary outcome
Device and Procedure Safety
Time frame: Implant through Day 90 after stimulation activation.
Proportion of participants experiencing at least one device or procedure related serious adverse event (SAE) from implantation through Day 90 after stimulation activation, including events such as intracranial hemorrhage, infection requiring explant or IV antibiotics, lead or hardware complications requiring surgical intervention, or other SAEs judged related to the DBS system, implantation procedure, or stimulation therapy.
1 secondary outcome
Overall Safety
Time frame: Implant through Day 90 after stimulation activation.
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 28 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Lisa Fosdick, MS study director
ReEmerge, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation in people with Chronic Traumatic Brain Injury and TBI (Traumatic Brain Injury), run by ReEmerge, Inc..
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 7 inclusion and 16 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: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Clinical Study Manager (800-000-0000, info@reemergedbs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device and Procedure Safety (time frame: Implant through Day 90 after stimulation activation.). 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 28 Jul 2026.