Clinical trial NCT06410001: CE-STAND: Cervical Epidural STimulation After Neurologic Damage
Official title: CE-STAND: Cervical Epidural STimulation After Neurologic Damage
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cervical Spinal Cord Injury
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 36
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in blood pressure
timeFrame: 1 year
measure: Changes in heart rate
timeFrame: 1 year
measure: Cognitive function
timeFrame: 1 year
measure: Cerebral blood flow
timeFrame: 1 year
measure: MSNA
timeFrame: 1 year
Secondary outcomes:
measure: Volitional function on electromyography (EMG)
timeFrame: 1 year
measure: Hand function using ISNCSCI
timeFrame: 1 year
measure: Hand function using GRASSP
timeFrame: 1 year
measure: Truncal stability
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: Ann Parr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Manda Keller-Ross, PhD, DPT, PT
role: PRINCIPAL_INVESTIGATOR
References: