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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Delivery of continuous, low-voltage electrical pulses to deep portions of the brain via an implantable pacemaker-like device.
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.
Time frame: Implant through Day 90 after stimulation activation.
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.
Time frame: Implant through Day 90 after stimulation activation.
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