Epidural Spinal Stimulation Clinical Trial
Clinical procedure troubleshooting, refinement and data collection.
The HEMO Trial is a clinical trial investigating the feasibility of using epidural spinal stimulation to stabilize blood pressure in individuals with spinal cord injuries. The trial is ongoing and many of the contributions I made are still used today.
I was a major contributor in the development and refinement of the majority of testing procedures for the HEMO trial (heavily involved in 23/38 procedures), in addition to collecting baseline data for two participants and developing a novel knee brace that allowed for spasticity testing to be conducted. I troubleshooted and refined 18 testing procedures, developed 11 SOPs and participant guides, validated and edited 75 data collection forms and conducted data acquisition for 9 testing procedures for two participants.
I gained expertise in the following areas: Spasticity isokinetic quantification, quality of life questionnaires, tilt test, trunk control, trunk stability, polysomnography, cardiovascular ultrasound, spirometry, x-ray, urodynamics, exercise capacity and pulse tonometry.
Figure 1: Recording blood pressure data during clinical testing.
Spasticity Isokinetic Quantification Testing
In addition to the knee attachment device design and fabrication (see project), I performed thorough troubleshooting of the experimental setup and conducted 10h+ of clinical data acquisition. I was responsible for Finapres blood pressure setup and acquisition throughout the test and informed the team of potentially dangerous blood pressure levels. Additionally, I developed an electromyography (EMG) sensor placement SOP based on anatomical models. This was effectively used by team members who did not have previous knowledge of placement location and enabled flexibility in the team members who could conduct the test.
Figure 2: Taking Blood Pressure Recordings during Spasticity Isokinetic Quantification Testing (including knee attachment I designed, fabricated and validated)
Tilt Test
The tilt test aims to measure how blood pressure and heart rate change during a rapid motion from supine to upright. I was responsible for experimental setup and refinement of this critical test in the trial. During testing I was responsible for acquiring and monitoring Finapres blood pressure data for multiple participants. This involved Finapres setup on the participant with a spinal cord injury, quantitative blood pressure monitoring and asking for self reported symptoms. I developed knowledge of patient specific blood pressure levels in order to notify the team if blood pressure levels were dropping to potentially dangerous levels.
As multiple other measures were being taken at the same time as the tilt test, resulting in confusion among team members, I increased experimental setup efficiency by developing an SOP outlining individual roles, tasks and materials.
Lastly, I increased safety of the tilt test my modifying the experimental equipment to include extra padding and comfort for the participant. This was critical with the spinal cord injury population as these individuals are unable to report self pain directly.
Within this test I was also trained on how to perform transcranial doppler and EKG experimental procedures.
Figure 3: Monitoring transcranial doppler & blood pressure data during tilt test with participant
Polysomnography
I was independently responsible for troubleshooting and setting up the polysomnography test equipment for clinical use. This involved research of how to use the experimental setup and thorough at home testing. My hands-on knowledge of the experimental setup made me a well equipped individual to develop a user guide for participants for ease of use during at-home testing.
Figure 4: Experimental setup testing (which I then wore while sleeping)
Trunk Control
This assessment quantified trunk control through various leaning actions against the participant on a pressure mat. I troubleshooted and taught PhD team members the procedure as I was a team expert on this procedure. I then successfully collected baseline participant data. After hearing directions from the principal investigator that setup times had to be cut down, I developed an SOP to outline team members’ roles and setup steps. This decreased the testing time and errors made in experimental setup.
Trunk Stability
In order to assess trunk stability, inertial measurement unit (IMU) sensors were placed on the participant and a dynamometer was used to push the individual until failure. I created a detailed IMU placement SOP based on anatomical models which enabled other team members to have the knowledge to set up the procedure. I acquired baseline data for two participants with qualitative observations and outcome scores, as well as instructed senior team members on how to conduct the test.
Vascular Ultrasound
In order to consistently collect high quality data, I performed a literature review of flow mediated dilation in the brachial and femoral artery which guided the probe and occlusion location used during data acquisition. Additionally, I received multiple training sessions on this procedure.
Quality of Life Questionnaires & SMART Trial
I was responsible for the verification and modification of 14 questionnaires which I inputted into the standard data collection software (SMART trial). In particular, I guided the use of the Goal Attainment Scale in the clinical trial through a literature review and contacting experts from other labs.
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I was independently responsible for reviewing and validating all data input options on SMART trial before it was released to participants. This involved streamlining the way forms were released to the participants and refining 75 forms.
Autonomic Dysreflexia Guide
I developed an autonomic dysreflexia guide to be given to participants in order to increase their at-home safety. With the use of reputable resources, I created an easy to follow step by step flow chart of symptoms and corresponding actions. This guide was utilized in a lab grant.
Spirometry
I troubleshooted the acquisition of spirometry data through LabChart which involved adjustment of LabChart parameters and formulas to collect the desired outcomes. This involved working with a LabChart representative, watching videos, and testing the spirometry equipment.
X-ray Scans
Through conversations with various X-ray clinics, I helped determine how required scan acquisition can be adapted to the spinal cord injury population. I then developed an X-ray Protocol summary outlining scans required. This was provided to the clinic to guide X-ray acquisition. I additionally helped source the location of the X-ray scans, reaching out to various clinics across Calgary.
Urodynamics
I was responsible for sourcing multiple components of the urodynamics system, as well as assisted in calibrating the system.