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UT Southwestern and UTMB awarded $500,000 TRC4 grant to study non-invasive neurostimulation for chronic subdural hematoma
Summary
The Trauma Research and Combat Casualty Care Collaborative has granted $500,000 to investigators at UT Southwestern and UTMB to fund a randomized, double-blind pilot trial testing transcutaneous auricular neurostimulation (tAN) with Spark Biomedical's Sparrow Link in patients with non‑surgical chronic subdural hematoma.
Content
A team at UT Southwestern and UTMB received a $500,000 Clinical Research Award from the Trauma Research and Combat Casualty Care Collaborative to test transcutaneous auricular neurostimulation (tAN) as a non‑invasive approach for chronic subdural hematoma (cSDH). The study is led by Dr. Alex Valadka at UT Southwestern with co-investigators Dr. Ryan Chiu (UTSW) and Dr. Peter Kan (UTMB). The trial will use Sparrow Link, a wearable neurostimulation platform developed by Spark Biomedical, which targets vagal and trigeminal pathways linked to inflammation and hemostasis. cSDH is a common neurosurgical condition with many current treatments that are invasive and carry risks, which is why non‑surgical approaches are being explored.
Key details:
- Grant: $500,000 Clinical Research Award from the Trauma Research and Combat Casualty Care Collaborative.
- Study leadership: Principal Investigator Dr. Alex Valadka (UT Southwestern) with co-investigators Dr. Ryan Chiu (UTSW) and Dr. Peter Kan (UTMB).
- Intervention: Sparrow Link wearable system delivering daily 30‑minute transcutaneous auricular neurostimulation (tAN) sessions self‑administered for one month.
- Design: Randomized, double‑blind, sham‑controlled pilot study enrolling 20 adults with cSDH deemed candidates for non‑operative management.
- Outcomes: Primary outcome is need for rescue surgical intervention; secondary measures include hematoma imaging (volume, midline shift, thickness) and biomarker analysis (CRP, cortisol, IL‑6 and others).
Summary:
The grant supports a pilot clinical trial testing whether daily, ear‑based neurostimulation can affect inflammatory and clotting pathways relevant to cSDH and influence the need for later surgical rescue. The next step is enrollment of 20 non‑operative cSDH patients into the randomized, sham‑controlled study, with outcomes measured by surgical rescue rates, imaging, and biomarkers.
