A neuro-cardiac self-regulation therapy to improve autonomic and neural function after SCI: a randomized controlled trial protocol
Ashley Craig,
Ilaria Pozzato,
Mohit Arora,
James Middleton,
Dianah Rodrigues,
Candice McBain,
Yvonne Tran,
Glen M. Davis,
Bamini Gopinath,
Annette Kifley,
Andrei Krassioukov,
Jeffrey Braithwaite,
Rebecca Mitchell,
Sylvia M. Gustin,
Jacob Schoffl,
Ian D. Cameron
Affiliations
Ashley Craig
John Walsh Centre Rehabilitation Research, Northern Sydney Local Health District, The Kolling Institute, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney
Ilaria Pozzato
John Walsh Centre Rehabilitation Research, Northern Sydney Local Health District, The Kolling Institute, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney
Mohit Arora
John Walsh Centre Rehabilitation Research, Northern Sydney Local Health District, The Kolling Institute, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney
James Middleton
John Walsh Centre Rehabilitation Research, Northern Sydney Local Health District, The Kolling Institute, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney
Dianah Rodrigues
John Walsh Centre Rehabilitation Research, Northern Sydney Local Health District, The Kolling Institute, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney
Candice McBain
John Walsh Centre Rehabilitation Research, Northern Sydney Local Health District, The Kolling Institute, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney
Yvonne Tran
Macquarie University Hearing (MU Hearing), Macquarie University
Glen M. Davis
Exercise and Sports Sciences, Faculty of Medicine and Health, The University of Sydney
Bamini Gopinath
Macquarie University Hearing (MU Hearing), Macquarie University
Annette Kifley
John Walsh Centre Rehabilitation Research, Northern Sydney Local Health District, The Kolling Institute, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney
Andrei Krassioukov
ICORD, Faculty of Medicine, University of British Columbia
Jeffrey Braithwaite
Centre for Healthcare Resilience and Implementation Science, Australian Institute of Health Innovation, Health Systems Research, Macquarie University
Rebecca Mitchell
Centre for Healthcare Resilience and Implementation Science, Australian Institute of Health Innovation, Health Systems Research, Macquarie University
Sylvia M. Gustin
School of Psychology, Faculty of Science, University of New South Wales
Jacob Schoffl
John Walsh Centre Rehabilitation Research, Northern Sydney Local Health District, The Kolling Institute, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney
Ian D. Cameron
John Walsh Centre Rehabilitation Research, Northern Sydney Local Health District, The Kolling Institute, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney
Abstract Background Spinal cord injury (SCI) is associated with autonomic imbalance and significant secondary conditions, including cardiac and brain dysfunction that adversely impact health and wellbeing. This study will investigate the effectiveness (intention-to-treat) of a neuro-cardiac self-regulation therapy to improve autonomic and neural/brain activity in adults with SCI living in the community. Methods A two-arm parallel, randomised controlled trial in which adults with SCI living in the community post-rehabilitation will be randomly assigned to a treatment or control group. The treatment group (N = 60) aged 18–70 years with a chronic traumatic or non-traumatic SCI, will receive intervention sessions once per week for 10 weeks, designed to regulate autonomic activity using computer-based feedback of heart rate variability and controlled breathing (called HRV-F). Comprehensive neurophysiological and psychological assessment will occur at baseline, immediate post-treatment, and 6 and 12-months post-treatment. Primary outcome measures include electrocardiography/heart rate variability (to assess autonomic nervous system function) and transcranial doppler sonography (to assess cerebral blood circulation in basal cerebral arteries). Secondary outcomes measures include continuous blood pressure, electroencephalography, functional near-infrared spectroscopy, respiration/breath rate, electrooculography, cognitive capacity, psychological status, pain, fatigue, sleep and quality of life. Controls (N = 60) will receive usual community care, reading material and a brief telephone call once per week for 10 weeks and be similarly assessed over the same time period as the HRV-F group. Linear mixed model analysis with repeated measures will determine effectiveness of HRV-F and latent class mixture modelling used to determine trajectories for primary and selected secondary outcomes of interest. Discussion Treatments for improving autonomic function after SCI are limited. It is therefore important to establish whether a neuro-cardiac self-regulation therapy can result in improved autonomic functioning post-SCI, as well as whether HRV-F is associated with better outcomes for secondary conditions such as cardiovascular health, cognitive capacity and mental health. Trial registration The study has been prospectively registered with the Australian and New Zealand Clinical Trial Registry ( ACTRN12621000870853 .aspx). Date of Registration: 6th July 2021. Trial Sponsor: The University of Sydney, NSW 2006. Protocol version: 22/07/2021.
