Restoring Hemodynamic Stability Using Targeted Epidural Spinal Stimulation Following Spinal Cord Injury (STIMO HEMO)
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| ClinicalTrials.gov Identifier: NCT04994886 |
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Recruitment Status :
Recruiting
First Posted : August 6, 2021
Last Update Posted : May 26, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Spinal Cord Injuries | Procedure: Device implantation | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 8 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Single-site, single-arm, non-blinded, non-randomized, interventional |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Restoring Hemodynamic Stability Using Targeted Epidural Spinal Stimulation Following Spinal Cord Injury |
| Actual Study Start Date : | June 8, 2021 |
| Estimated Primary Completion Date : | June 2023 |
| Estimated Study Completion Date : | June 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Targeted Epidural Spinal Stimulation
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. |
Procedure: Device implantation
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. |
- 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. [ Time Frame: From implantation through study completion, an average of 7 months ]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).
- ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury) [ Time Frame: At baseline and during the rehabilitation phase, an average of 7 months ]Clinical examination used to assess the motor and sensory impairment and severity of a spinal cord injury.
- Spasticity clinical exam using the Modified Ashworth Scale (MAS) [ Time Frame: At baseline and during the rehabilitation phase, an average of 7 months ]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.
- Spasticity isokinetic quantification [ Time Frame: At baseline and during the rehabilitation phase, an average of 7 months ]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).
- Spasticity isokinetic quantification [ Time Frame: At baseline and during the rehabilitation phase, an average of 7 months ]An extension and flexion movement is performed around each joint. EMG data is recorded through each movement.
- Trunk stability [ Time Frame: At baseline and during the rehabilitation phase, an average of 7 months ]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.
- Respiratory function evaluation [ Time Frame: At baseline and during the rehabilitation phase, an average of 7 months ]The respiratory function is evaluated using a spirometer. Volume is recorded.
- Respiratory function evaluation [ Time Frame: At baseline and during the rehabilitation phase, an average of 7 months ]The respiratory function is evaluated using a spirometer. Flow is recorded.
- Orthostatic head-up tilt test [ Time Frame: At baseline and during the rehabilitation phase, an average of 7 months ]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.
- Autonomic Dysfunction Following Spinal cord injury (ADFSCI) [ Time Frame: At baseline and monthly during the rehabilitation phase, an average of 7 months ]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.
- Quality of Life questionnaire WHOQOL-BREF [ Time Frame: At baseline and monthly during the rehabilitation phase, an average of 7 months ]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.
- Completion of a Daily Stimulation Log (DSL) by the patient [ Time Frame: From daily at-home supervised used until the end of the study, an average of 5 months ]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.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04994886
| Contact: Jocelyne Bloch, MD | 41795562951 | jocelyne.bloch@chuv.ch | |
| Contact: John-Paul Miroz | 41795568979 | John-Paul.Miroz@chuv.ch |
| Switzerland | |
| CHUV | Recruiting |
| Lausanne, Vaud, Switzerland, 1011 | |
| Contact: Jocelyne Bloch, MD 0041795562951 jocelyne.bloch@chuv.ch | |
| Contact: John-Paul Miroz 0041795568979 John-Paul.Miroz@chuv.ch | |
| Principal Investigator: | Jocelyne Bloch, MD | CHUV |
| Responsible Party: | Jocelyne Bloch, Professor, Neurosurgeon, Centre Hospitalier Universitaire Vaudois |
| ClinicalTrials.gov Identifier: | NCT04994886 |
| Other Study ID Numbers: |
STIMO-HEMO2021 |
| First Posted: | August 6, 2021 Key Record Dates |
| Last Update Posted: | May 26, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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SCI Spinal Cord Injury Epidural Spinal Stimulation |
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Spinal Cord Injuries Wounds and Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |