Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55415, United States
Location status: Recruiting
NCT Number: NCT07842458
This is a preliminary, prospective interventional feasibility study to investigate the use of cortical reverberation (CR) monitoring in patients with traumatic brain injury (TBI) requiring a clinically indicated external ventricular drain (EVD) placement.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Minneapolis, Minnesota, 55415, United States
Location status: Recruiting
Traumatic brain injury (TBI) is a major cause of death and disability and imposes burden on the health-system and society. Beyond the first impact of the injury, secondary brain injury processes, include elevated intracranial pressure (ICP), impaired autoregulation, seizures, and cortical spreading depolarizations (CSDs). These effects drive lesion expansion and worsen outcomes. Observational cohorts show that CSDs are common after severe TBI and that higher CSD burden results in worse recovery.
This is a preliminary, prospective interventional feasibility study to investigate the use of cortical reverberation (CR) monitoring in patients with traumatic brain injury (TBI) requiring a clinically indicated external ventricular drain (EVD) placement. EVDs are required to monitor and manage significant intracranial pressure. During standard-of-care EVD placement at the bedside in the intensive care unit (ICU), a single multi-contact depth electrode will be placed adjacent to the EVD catheter through the same burr hole. The electrode will be connected to a stimulator and recording system. Biphasic, charge-balanced intracortical pulses (1-6 mA, 60-1000 µs) will be delivered between adjacent contacts once every 3 seconds (0.33 Hz) for the duration of monitoring. Continuous electrocorticography (ECoG) will be recorded from the same electrode contacts. Recordings will be reviewed daily by a study neurosurgeon or an epileptologist for evidence of electrographic seizure activity. CR responses will be analyzed offline to assess feasibility, signal quality, and correlation with concurrent physiologic measures obtained from multimodal monitoring. The duration of study monitoring will be determined by the length of time that invasive neuromonitoring is clinically indicated. The depth electrode will be removed at the bedside once EVD monitoring is discontinued or the patient is discharged from the ICU.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Placement of a multi-contact depth electrode through the same burr hole created with a twist drill for clinically indicated EVD placement in TBI patients. The electrode will be positioned adjacent to the EVD catheter and connected to a stimulator/recording system to deliver biphasic, charge- balanced pulses (1-6 mA, 60-1000 µs) between adjacent contacts less than or equal to once every 3 seconds (0.33 Hz) while recording evoked cortical reverberation responses.
Other names: A stimulator/recording system, Cerestim
Time frame: through study completion, up to two years
A depth electrode is placed through the existing external ventricular drain (EVD) burr hole and used to deliver intracortical stimulation and record cortical reverberation (CR) responses. A participant is counted as meeting the endpoint if ≥24 cumulative hours of CR recording are obtained that pass predefined criteria and are judged suitable for feature extraction.
Time frame: through study completion, up to two years
Peak amplitude of the CR response evoked by intracortical stimulation, extracted from the recorded signal by an automated feature-extraction algorithm and reported in microvolts.
Time frame: through study completion, up to two years
Duration of the CR response evoked by intracortical stimulation, defined as the interval from response onset to return to baseline, extracted by an automated feature-extraction algorithm and reported in milliseconds.
Time frame: through study completion, up to two years
Rate of amplitude decay of the CR response evoked by intracortical stimulation, extracted by an automated feature-extraction algorithm and reported in microvolts per millisecond.
Time frame: through study completion, up to two years
Interval from delivery of the intracortical stimulus to onset of the CR response, extracted by an automated feature-extraction algorithm and reported in milliseconds.
Interested in participating?
Request InfoSamuel Cramer
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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