Delivering Transcutaneous Auricular Neurostimulation (tAN) to ICU Patients With Traumatic Brain Injury (tAN-TBI)
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The overarching goal of this pilot study is to assess the feasibility and safety of transcutaneous auricular neurostimulation (tan) in ICU patients with TBi and to determine the effect of tan on serum markers of inflammation. exploratory analyses will examine effects on such physiological parameters as blood pressure, heart rate, and intracranial pressure (iCP), as well as measures of neurological function.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Post-resuscitation GCS score 12 or below and acute trauma-related intradural blood on head CT scan after TB
• Age 18 years or older (pediatric trauma patients are not routinely transported to Parkland)
• Consent from legally authorized representative
Locations
United States
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Alex Valadka, MD
alex.valadka@utsouthwestern.edu
2146452300
Backup
Aisha Qureshi
Aisha.Qureshi@UTSouthwestern.edu
2146489905
Time Frame
Start Date: 2025-02-11
Estimated Completion Date: 2027-02-11
Participants
Target number of participants: 42
Treatments
Experimental: Determine the effect of tAN on serum concentrations of inflammatory mediators in TBI patients
Subjects will receive treatment upon providing informed consent and will undergo transcutaneous auricular neurostimulation (tAN) once daily during their ICU stay, with the treatment duration not exceeding 10 days. Two blood samples will be collected daily: one before the tAN session and another two hours after the session. Participant data will be collected daily throughout the ICU stay. Additionally, surveys will be collected from registered nurses providing direct care to TBI patients enrolled in the tAN-TBI study to assess the compatibility of tAN with patient care processes in the ICU.
Related Therapeutic Areas
Sponsors
Leads: University of Texas Southwestern Medical Center