Restoring Hemodynamic Stability Using Targeted Epidural Spinal Stimulation Following Spinal Cord Injury (STIMO HEMO)

Jocelyne Bloch

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Procedure: Device implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04994886

STIMO-HEMO2021

Details and patient eligibility

About

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.

Full 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).

Enrollment: 8 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Targeted Epidural Spinal Stimulation

Experimental group

Description:

Participants will undergo a surgery for Targeted Epidural Spinal Stimulation (TESS). The neurostimulation system will be used to manage blood pressure instability. Patients will then proceed to one month of an intensive device configuration protocol to configure the TESS settings of their investigational device to regain hemodynamic stability. After the intensive device configuration phase, daily supervised at-home hemodynamic TESS will be tested for 5 sessions per week for two weeks. Thereafter, and up to 10 months post-implant, patients will have a minimum of 5 TESS supported at-home sessions per week and one laboratory visit per month during a long-term at-home hemodynamic TESS phase. Finally, patients will have to undergo additional testing during a configuration of additional TESS programs phase. During this phase TESS configurations for hemodynamic stability, respiratory function, trunk stability and spasticity will be tested.

Treatment:

Procedure: Device implantation