Cognitive Network Restoration Therapy for Moderate to Severe Traumatic Brain Injury: A Feasibility Study

NCT07730099 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CNRT-001
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Traumatic Brain Injury; TBI (Traumatic Brain Injury)

Keywords

Deep Brain Stimulation; DBS; TBI; Central thalamus

Outcome Measures

Primary Outcomes (1)

• 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.

  Implant through Day 90 after stimulation activation.

Secondary Outcomes (1)

• Overall Safety

  Implant through Day 90 after stimulation activation.

Other Outcomes (5)

• Change in Trail Making Test Part B (TMT-B)

  Baseline through Day 90 after stimulation activation.

• Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ)

  Baseline through Day 90 after stimulation activation.

• Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) - Global Disability Score

  Baseline through Day 90 after stimulation activation.

Study Arms (1)

CT-DBS

EXPERIMENTAL

Participants will be treated with deep brain stimulation throughout the study.

Device: Deep brain stimulation

Interventions

Deep brain stimulation DEVICE

Delivery of continuous, low-voltage electrical pulses to deep portions of the brain via an implantable pacemaker-like device.

Also known as: CT-DBS, DBS

CT-DBS

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• ReEmerge, Inc.: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Lisa Fosdick, MS

  ReEmerge, Inc.

  STUDY DIRECTOR

Central Study Contacts

Clinical Study Manager

CONTACT

800-000-0000; info@reemergedbs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share