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

Overview

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.

Interventions

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

Primary outcome measures

• Device and Procedure Safety [Time frame: Implant through Day 90 after stimulation activation.]

Secondary outcome measures (1)

• Overall Safety [Time frame: Implant through Day 90 after stimulation activation.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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
• Any condition that, in the judgment of the PI, significantly increases risk or significantly reduces the likelihood of benefit from DBS

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07730099 · CNRT-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗