Traumatic Brain InjuryNCT07842458
Depth Electrode Cortical Reverberation Monitoring After Traumatic Brain Injury
A study testing A multi-contact depth electrode in people with Traumatic Brain Injury, run by Samuel Cramer at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- A multi-contact depth electrode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contaminated scalp lacerations
- Known systemic infection
- Non-English speaking
- Fixed, uncorrectable coagulopathy
- Pregnant, minors, or wards of the state
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55415
Samuel Cramer, MD, PhD, 6128739113, rnl@umn.edu
Samuel Cramer, MD, PhD
About this study
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.
Read the detailed description
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- A multi-contact depth electrode
- Keywords
- traumatic brain injury, brain injury, Cortical Reverberation, Depth Electrode, CSD, cortical spreading depolarization, tbi
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A multi-contact depth electrodeDevice
Also called A stimulator/recording system, Cerestim
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.
| Study group | Role | What they receive |
|---|---|---|
| TBI Patients | Other | This is a single-arm study. Receives: Device: A multi-contact depth electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, up to two years
Secondary outcomes (4)
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.
Measured: through study completion, up to two years
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.
Measured: through study completion, up to two years
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.
Measured: through study completion, up to two years
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.
Measured: through study completion, up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 May 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samuel Cramer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samuel Cramer, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842458
- Sponsor's protocol ID
- IRB-FY2025-1120
- Status last verified
- Sep 2026
- First submitted
- 29 May 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depth Electrode Cortical Reverberation Monitoring After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07842458
- Acronym / sponsor ID
- IRB-FY2025-1120
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, brain injury, Cortical Reverberation, Depth Electrode, CSD, cortical spreading depolarization, tbi
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Samuel CramerUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TBI Patients | Other | Device: A multi-contact depth electrodeThis is a single-arm study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Contaminated scalp lacerations
- Known systemic infection
- Non-English speaking
- Fixed, uncorrectable coagulopathy
- Pregnant, minors, or wards of the state
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A multi-contact depth electrodeAlso: A stimulator/recording system, CerestimPlacement 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. | Device | TBI Patients |
Primary outcome
Number of Participants With ≥24 Hours of Artifact-Controlled Cortical Reverberation Recordings Suitable for Analysis
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.
4 secondary outcomes
Amplitude of Cortical Reverberation Response
Time frame: through study completion, up to two years
Duration of Cortical Reverberation Response
Time frame: through study completion, up to two years
Decay Slope of Cortical Reverberation Response
Time frame: through study completion, up to two years
Latency of Cortical Reverberation Response
Time frame: through study completion, up to two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A multi-contact depth electrode in people with Traumatic Brain Injury, run by Samuel Cramer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With ≥24 Hours of Artifact-Controlled Cortical Reverberation Recordings Suitable for Analysis (time frame: through study completion, up to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.