Cognitive Network Restoration Therapy for Moderate to Severe Traumatic Brain Injury: A Feasibilit… (NCT07730099) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Cognitive Network Restoration Therapy for Moderate to Severe Traumatic Brain Injury: A Feasibility Study
40 participantsStarted 2027-02
Plain-language 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.
Who can participate
Age range
18 Years – 74 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Device and Procedure Safety
Timeframe: Implant through Day 90 after stimulation activation.
. 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.