Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury
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,
| Condition(s) | TBI (Traumatic Brain Injury) |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Post-resuscitation GCS score 12 or below and acute trauma-related intradural blood on head CT scan after TB 2. Age 18 years or older (pediatric trauma patients are not routinely transported to Parkland) 3. Consent from legally authorized representative Exclusion Criteria: 1. Hemodynamic instability 2. Expected imminent mortality because of overwhelming neurological and/or systemic injury 3. Unclear neurological status because of paralytic medications or intoxication with ethanol or other drugs 4. Presence of other electrical stimulation devices (pacemaker, cochlear prosthesis, neurostimulator, etc.) 5. Abnormal ear anatomy or ear infection 6. Participant is pregnant or lactating 7. Any other significant medical or psychosocial problems that, in the opinion of the inv |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Texas Southwestern Medical Center |
| Locations | Dallas, Texas, United States |
| Start date | 2025-02-11 |
| NCT ID | NCT06467708 |
| Official listing | https://clinicaltrials.gov/study/NCT06467708 |