CE-STAND: Cervical Epidural STimulation After Neurologic Damage

Launched by UNIVERSITY OF MINNESOTA · May 7, 2024

Keywords

ClinConnect Summary

The CE-STAND clinical trial is researching the use of a spinal cord stimulator to help improve the quality of life for people with chronic cervical spinal cord injuries. This study is particularly important because there have been very few studies focusing on this type of injury, and the aim is to better understand how stimulating the spinal cord can affect body functions that are often disrupted after such injuries. The trial will use a device made by Abbott Laboratories that has been approved for treating certain types of pain, but it is not yet approved for helping with movement or autonomic functions. Participants will take part in a "switch-on" and "switch-off" procedure to compare the effects of the stimulation.

To be eligible for this trial, participants must be at least 22 years old, have a stable spinal cord injury between the C4 and C7 vertebrae, and have experienced their injury for more than a year. They should also have intact reflexes below their injury and be able to attend all scheduled appointments. It's essential that they do not have certain medical conditions that could complicate their participation. If you or someone you know fits these criteria and is interested, the study will provide an opportunity to explore a new treatment approach that could enhance daily living for those affected by cervical spinal cord injuries.

Gender

ALL

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