Recruiting

Cortical Reverberation

Sponsor:

Samuel Cramer

Code:

NCT07842458

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

A multi-contact depth electrode

Study Details

Brief 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.

Conditions

Traumatic Brain Injury

Study ID

NCT07842458

Start date

May 1, 2026

Status verified date

Sep, 2026

Completion date

Jan 30, 2028

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 18 years or older
2. Consenting party must be able to provide written consent in English
3. Patient recommended to undergo EVD placement for the monitoring and possible treatment of ICP after TBI

Exclusion Criteria:

1. Contaminated scalp lacerations
2. Known systemic infection
3. Non-English speaking
4. Fixed, uncorrectable coagulopathy
5. Pregnant, minors, or wards of the state

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: TBI Patients

This is a single-arm study.

Interventions

A multi-contact depth electrode

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.

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 ]

Central Contacts and Locations

Locations

Hennepin Healthcare Research Institute

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Samuel Cramer, MD, PhD

6128739113rnl@umn.edu

Principal Investigator:

Samuel Cramer, MD, PhD

More Information

Sponsor

Samuel Cramer

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

  • traumatic brain injury
  • brain injury
  • Cortical Reverberation
  • Depth Electrode
  • CSD
  • cortical spreading depolarization
  • tbi

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Samuel Cramer on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.