The purpose of this study is to stimulate the circuits in the spinal cord that are directly responsible for hemodynamic control to restore hemodynamic stability in patients with chronic cervical or high-thoracic spinal cord injury. The ultimate objective of this feasibility study is to provide preliminary safety and efficacy measures on the ability of the hemodynamic Targeted Epidural Spinal Stimulation (TESS) to ensure the long-term management of hemodynamic instability and reduce the incidence and severity of orthostatic hypotension and autonomic dysreflexia episodes in humans with chronic cervical or high-thoracic spinal cord injury. In addition, the long-term safety and efficacy of TESS on cardiovascular health, respiratory function, spasticity, trunk stability and quality of life in patients with chronic spinal cord injury will be evaluated.
The investigators hypothesize that Targeted Epidural Spinal Stimulation (TESS) foreshadows a new era in the hemodynamic management of both acute and chronic SCI. It is envisioned that TESS will become the first-line treatment for hemodynamic instability in people with chronic SCI, where vasopressor agents and compression garments will become second-line treatments behind the precise control of blood pressure achieved with TESS. In this study, the investigators propose to investigate the preliminary safety of hemodynamic TESS to modulate pressor responses and manage blood pressure instability in 4 patients with chronic SCI located between C3 and T6 and who suffer from severe orthostatic hypotension. The study intervention consists of 8 phases preceded by pre-screening: * Screening and enrolment * Baseline and pre-implantation assessments * Surgery * Intensive TESS Configuration phase * Daily supervised at-home TESS phase * Long-term at-home phase * Configuration of additional TESS programs phase * End of study Measures will be performed before surgical intervention and at regular intervals during the study. The study will take place at the CHUV (Lausanne, Switzerland). A total of 4 participants will be enrolled in the study and implanted with two lead electrodes (Specify Surescan 5-6-5 Leads, Model 977C190 Medtronic) and two implantable pulse generators (Intellis™ with AdaptiveStim™, Model 97715 Medtronic). All participants will undergo the same treatment and procedures. The total duration of the study will be approximately 2 months (up to 10 months/participant).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
The intervention involves the insertion of 2 lead electrodes (Specify Surescan 5-6-5 Leads, Model 977C190 Medtronic) epidurally over the dorsal aspect of the spinal cord through 2 laminectomies and two implantable pulse generators (Intellis™ with AdaptiveStim™, Model 97715 Medtronic) in the abdomen of the participant.
CHUV
Lausanne, Canton of Vaud, Switzerland
Occurrence of Adverse Events and Serious Adverse Events that are deemed related or possibly related to the study procedure or to the study investigational system, from implant surgery until the end of study.
Investigate the preliminary safety of hemodynamic targeted epidural spinal stimulation (TESS) to modulate pressor responses and manage blood pressure instability in patients with chronic SCI located between C3 and T6 and who suffer from severe orthostatic hypotension (n=4).
Time frame: From implantation through study completion, an average of 7 months
ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury)
Clinical examination used to assess the motor and sensory impairment and severity of a spinal cord injury.
Time frame: At baseline and during the rehabilitation phase, an average of 7 months
Spasticity clinical exam using the Modified Ashworth Scale (MAS)
Patient's limb spasticity levels (5-point nominal scale) are assessed by rating the resistance of a muscle to a passive range of motion about a single joint. Scores range from 0 to 4 with higher scores indicating higher spasticity.
Time frame: At baseline and during the rehabilitation phase, an average of 7 months
Spasticity isokinetic quantification
A dynamometer (Cybex) is used to evaluate the effect of stimulation on spasticity of the hip, knee and ankle. An extension and flexion movement is performed around each joint (dynamometer in isokinetic mode).
Time frame: At baseline and during the rehabilitation phase, an average of 7 months
Spasticity isokinetic quantification
An extension and flexion movement is performed around each joint. EMG data is recorded through each movement.
Time frame: At baseline and during the rehabilitation phase, an average of 7 months
Trunk stability
The patient is asked to perform a systematic set of reaching movements while seated freely (without a back-rest). Additionally, the patient is asked to perform a set of movements deemed functionally relevant, for example reaching for an object behind them or picking up an object from the ground. Each movement is repeated and EMG data can be acquired.
Time frame: At baseline and during the rehabilitation phase, an average of 7 months
Respiratory function evaluation
The respiratory function is evaluated using a spirometer. Volume is recorded.
Time frame: At baseline and during the rehabilitation phase, an average of 7 months
Respiratory function evaluation
The respiratory function is evaluated using a spirometer. Flow is recorded.
Time frame: At baseline and during the rehabilitation phase, an average of 7 months
Orthostatic head-up tilt test
Patients begin by resting in the supine position during which a baseline recording is performed. Thereafter, patients will be passively moved to upright position using the tilt-table. Between each experimental condition, the patient will be moved back in supine position to return to baseline. Beat-to-beat blood pressure will be monitored.
Time frame: At baseline and during the rehabilitation phase, an average of 7 months
Autonomic Dysfunction Following Spinal cord injury (ADFSCI)
The ADFSCI questionnaire is a 24-item self-reported questionnaire. The questionnaire consists of demographics, medications, frequency/severity of symptoms during AD and hypotensive events. Higher scores indicate more severe and more frequent symptoms during AD and hypotensive events.
Time frame: At baseline and monthly during the rehabilitation phase, an average of 7 months
Quality of Life questionnaire WHOQOL-BREF
The WHOQOL-BREF is a questionnaire used to assess the quality of life. Scores are converted to range between 4-20 or 0-100 and are scaled in a positive direction: higher scores denote higher quality of life.
Time frame: At baseline and monthly during the rehabilitation phase, an average of 7 months
Completion of a Daily Stimulation Log (DSL) by the patient
The patient will be asked to self-report the use of TESS during the at-home phases. This information will be used to evaluate hemodynamic TESS-supported at-home stimulation sessions and characterize the use of the investigational system at home.
Time frame: From daily at-home supervised used until the end of the study, an average of 5 months
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