CE-STAND: Cervical Epidural STimulation After Neurologic Damage

Cervical Spinal Cord Injury Clinical Trial

Official title:

CE-STAND: Cervical Epidural STimulation After Neurologic Damage

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06410001
• Other study ID #: NEUROSURG-2023-31800
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: June 1, 2024
• Est. completion date: June 1, 2028

Study information

• Verified date: May 2024
• Source: University of Minnesota
• Contact: Nadine Mansour
• Email: nmansour[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Research on chronic cervical injuries is under-represented. There are very few studies in this arena, and none that utilize gold-standard techniques to measure sympathetic activity. This proposal aims to address all three of these highlighted areas: cervical, chronic, and autonomic dysfunction, and thus is both significant and highly impactful, as treating autonomic dysfunction could substantially improve function and quality of life (QoL) in chronic cervical SCI patients. Further, we will use microneurography, a novel technique to measure muscle sympathetic nerve activity (MSNA) to quantify autonomic function in cervical SCI.

The spinal cord stimulator system (Abbott Eterna system implantable pulse generator (IPG), charger, and TriCentrus lead) will be used for this study which is manufactured by Abbott Laboratories. The stimulators are commercially marketed and they are Food and Drug Administration (FDA) approved for use in chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome and intractable low back and leg pain. While they can be used in SCI patients who suffer from any of these above-mentioned things, they are not approved for restoration of voluntary movement and/or autonomic dysfunction. Therefore, The CE-STAND study is a treatment based investigation. Because it is exploring both safety and efficacy, it is classified as a Phase I/II study, and thus, it is not expected to support a marketing application. The study model is a single group with "eSCS on" as the intervention and "eSCS off" as the control, with participants acting as their own controls.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: June 1, 2028
• Est. primary completion date: June 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Twenty two years of age or older

• Able to undergo the informed consent/assent process

• Stable, motor-complete SCI

• Discrete SCI between C4 and C7 (upper extremity weakness)

• ASIA A or B SCI Classification

• Medically stable in the judgment of the PI

• Intact segmental reflexes below the lesion of injury

• Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation

• Normal or corrected-to-normal vision to accurately perceive visual stimuli on the N-back task screen, and sufficient hearing ability to accurately perceive auditory stimuli during the task

• Willing to attend all scheduled appointments

Exclusion Criteria:

• Upper cervical injury

• Diseases and conditions that would increase the morbidity and mortality of this surgery such as cardiopulmonary.

• Individuals who require respiratory support, including ongoing or intermittent use of a ventilator and/or diaphragmatic pacer

• Inability to withhold antiplatelet/anticoagulation agents perioperatively

• Individuals who have history of recurrent autonomic dysreflexia in the judgment of the PI

• Significant dysautonomia that would prohibit rehabilitation or any history of cerebrovascular accident or myocardial infarction associated with autonomic dysreflexia. A single tilt table test with syncope, presyncope, or SBP < 50 or > 200

• Failure to exhibit cardiovascular autonomic dysfunction on tilt table testing

• Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgment of the PI

• Patients who have participated in another study within the last 12 months in which they have received fluoroscopic or other related radiation exposure

• Current and anticipated need for opioid pain medications or pain that would prevent full participation in the program in the judgment of the PI

• Clinically significant mental illness in the judgment of the PI

• Treatment with botulinum toxin, intrathecal baclofen pump, and antispasmodics will not be permitted unless discussed with and approved by the study PI

• Patients with a history of significant depression or drug abuse

• Volitional movements present during EMG testing in bilateral lower extremities

• Unhealed spinal fracture

• Presence of significant contracture with loss of greater than two-thirds range of motion

• Presence of pressure ulcers

• Current Pregnancy

Related Conditions & MeSH terms

• Cervical Spinal Cord Injury
• Spinal Cord Injuries

Intervention

Device:
• Epidural Spinal Cord Stimulation (eSCS)
The spinal cord stimulator system (Abbott Eterna system implantable pulse generator (IPG), charger, and TriCentrus lead) will be used for this study which is manufactured by Abbott Laboratories. The The stimulators will be surgically inserted above the dura in the spinal canal and administer an electrical signal from the neurostimulator to specific sections of the spinal cord underlying the electrodes. The duration of implantation will be 10 years (the longevity of the device battery). The device will not be removed unless it causes complications such as malfunction, illness, or other harm. The device can also be removed electively for any reason.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in blood pressure	measured on tilt table testing. Both systolic and diastolic pressure will be assessed	1 year
Primary	Changes in heart rate	measured on tilt table testing	1 year
Primary	Cognitive function	measured using N-back testing	1 year
Primary	Cerebral blood flow	measured using transcranial doppler	1 year
Primary	MSNA	microneurolography	1 year
Secondary	Volitional function on electromyography (EMG)	using the modified brain motor control assessment (mBMCA) and the volitional response index (VRI); The modified Brain and Motor Control Assessment (mBMCA) will be utilized, and volitional responses will be measured using electromyography (EMG). The Volitional Response Index (VRI) will be employed to quantify these responses.	1 year
Secondary	Hand function using ISNCSCI	using the International Standards for Neurological Classification of SCI (ISNCSCI)	1 year
Secondary	Hand function using GRASSP	The Graded Redefined Assessments of Strength, Sensibility, and Prehension (GRASSP) functional score	1 year
Secondary	Truncal stability	using the modified Multidirectional reach test (mMDRT)	1 year