Connectomic profiling and Vagus nerve stimulation Outcomes Study (CONNECTiVOS): a prospective observational protocol to identify biomarkers of seizure response in children and youth
Howard L Weiner,
Han Yan,
Melissa LoPresti,
Elysa Widjaja,
George M Ibrahim,
Lauren Siegel,
Nebras Warsi,
Simeon Wong,
Hrishikesh Suresh,
Alexander G Weil,
John Ragheb,
Shelly Wang,
Curtis Rozzelle,
Gregory W Albert,
Jeffrey Raskin,
Taylor Abel,
Jason Hauptman,
Dewi V Schrader,
Robert Bollo,
Matthew D Smyth,
Sean M Lew,
Dominic J Kizek,
Aria Fallah
Affiliations
Howard L Weiner
Department of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA
Han Yan
Department of Anaesthesiology, Shanghai Cancer Centre, Fudan University, Shanghai, People`s Republic of China
Melissa LoPresti
Department of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA
Elysa Widjaja
Department of Diagnostic Imaging, Hospital for Sick Children, Toronto, Ontario, Canada
George M Ibrahim
Division of Neurosurgery, Hospital for Sick Children, Department of Neurosurgery, University of Toronto, Toronto, Ontario, Canada
Lauren Siegel
Program in Neuroscience and Mental Health, Hospital for Sick Children Research Institute, Toronto, Ontario, Canada
Nebras Warsi
Division of Neurosurgery, Hospital for Sick Children, Department of Neurosurgery, University of Toronto, Toronto, Ontario, Canada
Simeon Wong
Program in Neuroscience and Mental Health, Hospital for Sick Children Research Institute, Toronto, Ontario, Canada
Hrishikesh Suresh
Division of Neurosurgery, Hospital for Sick Children, Department of Neurosurgery, University of Toronto, Toronto, Ontario, Canada
Alexander G Weil
Pediatric Neurosurgery, Department of Surgery, Sainte Justine Hospital, University of Montreal, Montreal, Quebec, Canada
John Ragheb
Division of Neurosurgery, Nicklaus Children`s Hospital, Miami, Florida, USA
Shelly Wang
Division of Neurosurgery, Nicklaus Children`s Hospital, Miami, Florida, USA
Curtis Rozzelle
Department of Neurosurgery, University of Alabama at Birmingham, Birmingham, Alabama, USA
Gregory W Albert
Department of Neurosurgery, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA
Jeffrey Raskin
Department of Neurological Surgery, Indiana University School of Medicine, Indianapolis, Indiana, USA
Taylor Abel
Department of Neurological Surgery, UPMC Children`s Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA
Jason Hauptman
Department of Neurosurgery, Seattle Children`s Hospital, Seattle, Washington, USA
Dewi V Schrader
Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada
Robert Bollo
Department of Neurosurgery, University of Utah, Salt Lake City, Utah, USA
Matthew D Smyth
Department of Neurosurgery, Washington University School of Medicine in St Louis, Milwaukee, Wisconsin, USA
Sean M Lew
Department of Neurosurgery, Children`s Hospital of Wisconsin, Milwaukee, Wisconsin, USA
Dominic J Kizek
Department of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA
Aria Fallah
University of California Los Angeles, Los Angeles, California, USA
Introduction Vagus nerve stimulation (VNS) is a neuromodulation therapy that can reduce the seizure burden of children with medically intractable epilepsy. Despite the widespread use of VNS to treat epilepsy, there are currently no means to preoperatively identify patients who will benefit from treatment. The objective of the present study is to determine clinical and neural network-based correlates of treatment outcome to better identify candidates for VNS therapy.Methods and analysis In this multi-institutional North American study, children undergoing VNS and their caregivers will be prospectively recruited. All patients will have documentation of clinical history, physical and neurological examination and video electroencephalography as part of the standard clinical workup for VNS. Neuroimaging data including resting-state functional MRI, diffusion-tensor imaging and magnetoencephalography will be collected before surgery. MR-based measures will also be repeated 12 months after implantation. Outcomes of VNS, including seizure control and health-related quality of life of both patient and primary caregiver, will be prospectively measured up to 2 years postoperatively. All data will be collected electronically using Research Electronic Data Capture.Ethics and dissemination This study was approved by the Hospital for Sick Children Research Ethics Board (REB number 1000061744). All participants, or substitute decision-makers, will provide informed consent prior to be enrolled in the study. Institutional Research Ethics Board approval will be obtained from each additional participating site prior to inclusion. This study is funded through a Canadian Institutes of Health Research grant (PJT-159561) and an investigator-initiated funding grant from LivaNova USA (Houston, TX; FF01803B IIR).
