1000 Section - A feasibility study on the use of vagal nerve stimulation for Post-Traumatic Brain Injury Autonomic Dysfunction

Objectives : Chronic autonomic symptoms after traumatic brain injury (TBI) can have a significant impact on quality of life and are known to correlate with TBI severity. However, the incidence is not known due to lack of screening and agreed objective measures.
Currently, we do not delineate autonomic symptoms post TBI and offer no targeted interventions.
We hypothesise that non-invasive vagal nerve stimulation (VNS) may be effective for post TBI autonomic dysfunction. A handheld device delivers electrical impulses through the skin to the vagus nerve. It has been shown to improve autonomic symptoms in other conditions (eg. POTS) and is safe and well tolerated. Its effects on chronic autonomic dysfunction post TBI are yet to be tested, but has the potential to be a cost-effective and easy to use treatment.
The purpose of our study is to assess the feasibility of a trial of VNS for TBI patients with autonomic dysfunction.

Design: We will use a before and after study design with 10 patients. Patients will be recruited through existing rehabilitation clinics and eligible if they have a TBI at least 4 weeks prior and autonomic symptoms reported using the COMPASS-31 questionnaire. All consented patients will be provided with a VNS device to use at home for four weeks, with two 10 minute applications twice a day. Pre- and post-intervention data will include subjective measures (COMPASS-31 and EQ-5D-5L questionnaires) and objective (NASA lean test and heart rate variability). Post-intervention data will include: compliance, acceptability, barriers and facilitators to use, and adverse effects.

Results: The study will run 2026-2027.

Conclusion: This feasibility study will prepare us for future work trialling VNS efficacy and optimum protocol for post TBI autonomic dysfunction. It will also lead into research of VNS for other indications within Rehabilitation Medicine, such as: paroxysmal sympathetic hyperactivity, post-concussion syndrome, post-TBI depression, and deconditioning.