Connectomic profiling and Vagus nerve stimulation Outcomes Study (CONNECTiVOS): a prospective observational protocol to identify biomarkers of seizure response in children and youth
Siegel L, Yan H, Warsi N, Wong S, Suresh H, Weil AG, Ragheb J, Wang S, Rozzelle C, Albert GW, Raskin J, Abel T, Hauptman J, Schrader DV, Bollo R, Smyth MD, Lew SM, Lopresti M, Kizek DJ, Weiner HL, Fallah A, Widjaja E, Ibrahim GM.
BMJ Open 2022;12:e055886.
https://doi.org/10.1136/bmjopen-2021-055886
A new publication in BMJ Open describes the study protocol of the Connectomic profiling and Vagus nerve stimulation Outcomes Study (CONNECTiVOS), a #prospective #observational study that aims to distinguish the optimal surgical candidate for vagus nerve stimulation (#VNS) Therapy by identifying clinical and multimodal neuroimaging data correlating with VNS response.
This multicenter study intends to recruit up to 500 pediatric patients (0-18 years old) undergoing VNS surgery across 14 different centers in North America. Outcome measurements will include changes in seizure burden, health-related quality of life (measured by standardized questionnaires aimed towards the patient/caregiver or the treating physician), and the use of health care resources, with a follow-up duration of up to 2 years. Furthermore, pre and postoperative neuroimaging will be performed to identify structural and functional correlates to VNS response. The imaging connectomics of the vagal afferent network and the observed VNS response will be translated into a machine learning algorithm to create a prediction model for identifying optimal surgical candidates for VNS Therapy. This prediction model will be freely available for other clinicians/researchers and may thus provide a helpful tool in identifying children that benefit the most from VNS Therapy.
