NCT07842458

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
16mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
May 2026Jan 2028

Study Start

First participant enrolled

May 1, 2026

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2028

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

9 months

First QC Date

May 29, 2026

Last Update Submit

September 21, 2026

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injurybrain injuryCortical ReverberationDepth ElectrodeCSDcortical spreading depolarizationtbi

Outcome Measures

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.

    through study completion, up to two years

Secondary Outcomes (4)

  • Amplitude of Cortical Reverberation Response

    through study completion, up to two years

  • Duration of Cortical Reverberation Response

    through study completion, up to two years

  • Decay Slope of Cortical Reverberation Response

    through study completion, up to two years

  • Latency of Cortical Reverberation Response

    through study completion, up to two years

Study Arms (1)

TBI Patients

OTHER

This is a single-arm study.

Device: A multi-contact depth electrode

Interventions

A multi-contact depth electrodeDEVICE

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.

Also known as: A stimulator/recording system, Cerestim
TBI Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Contaminated scalp lacerations
  • Known systemic infection
  • Non-English speaking
  • Fixed, uncorrectable coagulopathy
  • Pregnant, minors, or wards of the state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55415, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 29, 2026

First Posted

September 25, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

January 30, 2028

Last Updated

September 25, 2026

Record last verified: 2026-09

Locations

US(1)