DOI: 10.34945/f5hp4n
title: Hemodynamic stability, incidence of pain, skin redness, autonomic dysreflexia and other safety related outcome measures of transcutaneous electrical spinal cord stimulation in children with cervical and thoracic spinal cord injuries

description: STUDY PURPOSE: This was a pilot study to establish the safety and feasibility of transcutaneous electrical spinal cord stimulation (scTS) to augment upright sitting posture and trunk control in children with spinal cord injury. DATA COLLECTED: The primary safety-related outcome measures were assessed over the 3 days for each participant and included: hemodynamic stability assessed using brachial arm blood pressure (mmHg) and heart rate (beats per minute) at baseline (no stimulation), during stimulation, at the end of experiments and if a child presents with symptoms of autonomic dysreflexia (e.g. facial flushing, reporting of headache, etc); incidence of autonomic dysreflexia (increase in blood pressure over 20 mmHg from a previous blood pressure measurement); incidence of pain in response to stimulation (assessed using FACES Pain Scale-Revised for children under 8 and Visual Analogue Scale for children 8 and older); incidence of skin redness under the stimulating electrodes. Trunk kinematics and center of pressure displacement data are published as a separate dataset on ODC-SCI titled: "Trunk kinematic and center of pressure displacement time series data during transcutaneous lumbosacral spinal cord stimulation and passive pelvic tilt in human pediatric participants with trunk control impairments due to cervical or thoracic spinal cord injury (pilot clinical trial NCT03975634)" DATA USAGE NOTES: Lumbosacral scTS is well-tolerated in 8 out 9 children with SCI whose injury level is at least two segments above the placement of the stimulating electrodes (T11 and L1). Stimulation was not tolerated by one of the participants with skin hypersensitivity or allodynia whose injury level coincided with the placement of stimulating electrodes. Second, overall continuous scTS (5-30 minutes) did not adversely affect hemodynamic parameters which remained stable (average systolic blood pressure (SBP) at baseline was 101.9 +/- 6.24 mmHg, SBP with scTS on was 102.1 +/- 12. 3 mmHg, post-stim SBP = 105.3 +/- 9.29 mmHg; average diastolic blood pressure (DBP) at baseline was 61.3 +/- 3.9 mmHg, average DBP with scTS on was 63.3 +/- 7.4 mmHg and average DBP post stim was 64.2 +/- 8.2 mmHg; average heart rate (HR) at baseline was 91.3 +/- 13.4 beat per minute (BPM), average HR with scTS on was 90.8 +/- 15 BPM, average HR post stim was 91.6 +/- 15.6 BPM. One episode of autonomic dysreflexia (AD) was captured in the youngest (3 year old) participant (P49) with scTS stimulation on at cervical level. P49’s blood pressure was measured and recorded at 134/82 mmHg with a heart rate (HR) of 58 beats per minute (bpm). There was a 27 mmHg increase in systolic blood pressure with a concomitant decrease in HR by 40 bpm from baseline measurement (107/67 mmHg, HR 98 bpm). The stimulation was stopped and the participant was monitored carefully. Within 3 minutes the episode resolved, with a follow up blood pressure of 114/82 mmHg and a HR of 94 bpm. Third, skin redness was observed in 9 out 22 assessments (with a calculated incidence likelihood of 41%) following the experiments, but dissipated without special measures within a few hours. Additionally, lower extremity motor responses were observed in 14 out of 22 experiments ( with a calculated incidence likelihood of 64%). We have recorded those instances as potentially strong hip extensor responses at higher stimulation intensities could lead to participants' loss of balance. Thus, a child should always be spotted during stimulation optimization procedures. Please see the associated manuscript for a complete list of results.