Depth Electrode Cortical Reverberation Monitoring After Traumatic Brain Injury
ConditionTraumatic Brain Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSamuel Cramer
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
Consenting party must be able to provide written consent in English
Patient recommended to undergo EVD placement for the monitoring and possible treatment of ICP after TBI
Disqualifiers
Contaminated scalp lacerations
Known systemic infection
Non-English speaking
Fixed, uncorrectable coagulopathy
Trial design
Design model
Single group
Treatments tested in this trial
A multi-contact depth electrode
DevicePlacement 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: TBI PatientsOther 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With ≥24 Hours of Artifact-Controlled Cortical Reverberation Recordings Suitable for Analysis
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 yearsSecondary outcomes
1
Amplitude of Cortical Reverberation Response
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 years2
Duration of Cortical Reverberation Response
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 years3
Decay Slope of Cortical Reverberation Response
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 years4
Latency of Cortical Reverberation Response
Interval from delivery of the intracortical stimulus to onset of the CR response, extracted by an automated feature-extraction algorithm and reported in milliseconds.
Time frame
through study completion, up to two yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Samuel Cramer
Lead sponsor
Hennepin Healthcare Research Institute
Sponsor institution
Source ClinicalTrials.gov