Clinical trial NCT04994886: Restoring Hemodynamic Stability Using Targeted Epidural Spinal Stimulation Following Spinal Cord Injury
Official title: Restoring Hemodynamic Stability Using Targeted Epidural Spinal Stimulation Following Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: SCI
Spinal Cord Injury
Epidural Spinal Stimulation
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-site, single-arm, non-blinded, non-randomized, interventional
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Age 18 to 70 years old
* Able to undergo the informed consent/assent process
* Radiologically confirmed spinal cord injury
* Spinal cord injury between C3 and T6
* Classified with AIS A or B Spinal cord injury
* Stable medical, physical and psychological condition as considered by Investigators
* Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation
* Confirmed orthostatic hypotension and autonomic dysreflexia
* Willing to attend all scheduled appointments

Exclusion Criteria:

* Patients in an emergency situation
* Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery
* The inability to withhold antiplatelet/anticoagulation agents perioperatively
* History of myocardial infarction or cerebrovascular event
* Other conditions that would make the subject unable to participate in testing in the judgment of the investigators
* Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgement of the investigators
* Clinically significant mental illness in the judgment of the investigators
* Botulinum toxin injections in the previous 6 months
* Presence of significant pressure ulcers
* Recurrent urinary tract infection refractory to antibiotics
* Current pregnancy
* Current breastfeeding
* Known or suspected drug or alcohol abuse
* Unhealed spinal fractures
* Presence of indwelling baclofen or insulin pump

Primary outcomes:
measure: 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.
timeFrame: From implantation through study completion, an average of 7 months
Secondary outcomes:
measure: ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury)
timeFrame: At baseline and during the rehabilitation phase, an average of 7 months
measure: Spasticity clinical exam using the Modified Ashworth Scale (MAS)
timeFrame: At baseline and during the rehabilitation phase, an average of 7 months
measure: Spasticity isokinetic quantification
timeFrame: At baseline and during the rehabilitation phase, an average of 7 months
measure: Spasticity isokinetic quantification
timeFrame: At baseline and during the rehabilitation phase, an average of 7 months
measure: Trunk stability
timeFrame: At baseline and during the rehabilitation phase, an average of 7 months
measure: Respiratory function evaluation
timeFrame: At baseline and during the rehabilitation phase, an average of 7 months
measure: Respiratory function evaluation
timeFrame: At baseline and during the rehabilitation phase, an average of 7 months
measure: Orthostatic head-up tilt test
timeFrame: At baseline and during the rehabilitation phase, an average of 7 months
measure: Autonomic Dysfunction Following Spinal cord injury (ADFSCI)
timeFrame: At baseline and monthly during the rehabilitation phase, an average of 7 months
measure: Quality of Life questionnaire WHOQOL-BREF
timeFrame: At baseline and monthly during the rehabilitation phase, an average of 7 months
measure: Completion of a Daily Stimulation Log (DSL) by the patient
timeFrame: From daily at-home supervised used until the end of the study, an average of 5 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
state: Vaud
Study officials:
affiliation: CHUV
name: Jocelyne Bloch, MD
role: PRINCIPAL_INVESTIGATOR
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