The effect of Heart Rate Variability Feedback to improve heart-brain function after spinal cord injury - The Spinal cord injury, Mind and HeART or (SMART) study

Not Applicable

• Conditions: Spinal Cord Injury (SCI); Autonomic dysfunction; Neurological - Other neurological disorders; Cardiovascular - Other cardiovascular diseases; Mental Health - Other mental health disorders

• Registration Number: ACTRN12621000870853
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-06
• Last Update Posted: 12 September 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

A participant will be included if:
(i) aged 18-80 years
(ii) English speaking
(iii) have sustained a SCI of traumatic/non-traumatic aetiology with complete/incomplete lesions
(iv) at least 12 months post-SCI

Exclusion Criteria

A participant will be excluded if:
(i) there is evidence of severe cognitive impairment, e.g. moderate to severe traumatic brain injury (TBI) or dementia or determined by cognitive screening (e.g. NUCOG);
(ii) evidence of psychiatric disorder, e.g. bipolar disorder or psychoses or chronic severe depression disorder, determined by medical history or psychiatric interview (e.g. PHQ9);
(iii) taking ß-blockers;
(iv) compromised respiratory functions, e.g. mechanical ventilation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short-term changes in heart rate variability (HRV) time domain from the recorded electrocardiograph (ECG) trace, assessing the amount of the HR variability observed.[Baseline (pre-intervention) to 10 weeks post commencement of intervention (short term outcome).];Short-term changes in heart rate variability (HRV) frequency domain from the recorded electrocardiograph (ECG) trace, assessing the underlying rhythms of the HR variability observed by quantifying the power within component bands.[Baseline (pre-intervention) to 10 weeks post commencement of intervention (short term outcome).];Short-term changes in cerebral blood circulation, assessed by mean/beat-to-beat cerebral blood flow velocity (CBF-V) of the basal cerebral arteries using a transcranial doppler sonography (fTCD) non-invasive system.[Baseline (pre-intervention) to 10 weeks post commencement of intervention (short term outcome).]