Cognitive Network Restoration Therapy for Moderate to Severe Traumatic Brain Injury: A Feasibility Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-74
SponsorReEmerge, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Deep brain stimulation
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov