NCT07094230

Brief Summary

Use of blood biomarkers and eye tracking after traumatic brain injury for recovery timeline prediction

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Aug 2025Aug 2026

First Submitted

Initial submission to the registry

July 23, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

July 23, 2025

Last Update Submit

July 29, 2025

Conditions

Blood

Keywords

mTBIbiomarkersIR Oculography

Outcome Measures

Primary Outcomes (1)

  • blood biomarkers analyses

    Alinity device analyses of GFAP and UCH-L1

    same day

Study Arms (1)

blood biomarkers analyses

EXPERIMENTAL

blood biomarkers analyses

Diagnostic Test: biomarkers analyses

Interventions

biomarkers analysesDIAGNOSTIC_TEST

blood analyses

blood biomarkers analyses

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-85, Communicative in English language, With clinician-confirmed mTBI (GCS 13-15, ≤24 hours post-injury)

You may not qualify if:

  • Neurological, vestibular, or visual disorders, Significant comorbidities, Prior TBI (\<6 months) Special populations (pregnant, incarcerated, active-duty recruits). Active-duty recruits excluded due to inability to contact them at scheduled intervals for remote follow-up questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Captain James A. Lovell Federal Health Care Center

North Chicago, Illinois, 60064, United States

Location

Related Links

Study Officials

  • James Buskirk, PT, DPT, PhD, MS

    Captain James A. Lovell Federal Health Care Center

    STUDY DIRECTOR

Central Study Contacts

Bharathi Swaminathan, MD

CONTACT

224-610-4152Bharathi.Swaminathan2@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Investigator

Study Record Dates

First Submitted

July 23, 2025

First Posted

July 30, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

blood analyses results, IR Oculography results, recovery timelines questionnaires data

Shared Documents
SAP
Time Frame
August 1, 2025 -- August 1, 2026
Access Criteria
Rosalind Franklin University Dept of Statistics, IPD, via electronic data transfer
More information

Locations

US(1)