Clinical trial NCT05095454: Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With SCI
Official title: A Pilot Study to Compare Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paraplegia
Tetraplegia
Paralysis
Quadraplegia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 6
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A study comparing short-term delivery of epidural spinal stimulation versus transcutaneous spinal stimulation.

Detailed description: The purpose of this study is to compare spinal motor nerve response to electrical stimulation delivered directly to the epidural space, and delivered through the skin (transcutaneously), and to measure any changes in motor performance over the course of about 5 months, during and after using one of the two types of stimulation.

Eligibility criteria: Inclusion Criteria:

* Spinal cord injury due to trauma located at or above the tenth thoracic vertebrae (T10)
* American Spinal Injury Association grading scale of A-D (2 from each) below the level of SCI
* Intact spinal reflexes below the level of SCI
* At least 1-year post-SCI
* At least 22 years of age
* Willing to use medically acceptable methods of contraception, if female and of child-bearing potential

Exclusion Criteria:

* Currently a prison inmate, or awaiting trial, related to criminal activity
* Pregnancy at the time of enrollment
* History of chronic and/or treatment resistant urinary tract infection
* Unhealed decubitus ulcer
* Unhealed skeletal fracture
* Untreated clinical diagnosis of depression
* Undergoing, or planning to undergo, diathermy treatment
* Active participation in another interventional clinical trial
* Presence of conditions or disorders which require MRI monitoring
* A history of coagulopathy or other significant cardiac or medical risk factors for surgery
* Current use of a ventilator
* Clinically diagnosed cardiopulmonary complications such as chronic obstructive pulmonary disease, cardiac failure, or heart arrhythmia that contraindicate changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping
* History of frequent hypotension characterized by light headedness, or loss of consciousness
* History of frequent hypertension characterized by headache, or bradycardia
* History of frequent, severe, autonomic dysreflexia
* Any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.

Primary outcomes:
measure: Electromyography
timeFrame: Through study completion; an average of 5 months.
measure: Foot Pressure
timeFrame: Beginning of intervention to end of intervention, an average of 17 days.
measure: Somatosensory Evoked Potentials
timeFrame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
measure: Transcranial Magnetic Stimulation Motor Evoked Potentials
timeFrame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
measure: Injury Severity: International Standards for Neurological Classification of Spinal Cord Injury
timeFrame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
measure: Patient-reported Bowel Function
timeFrame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
measure: Patient-reported Bladder Function
timeFrame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
measure: Male Patient-reported Sexual Function (1)
timeFrame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
measure: Male Patient-reported Sexual Function (2)
timeFrame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
measure: Female Patient-reported Sexual Function
timeFrame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
measure: Spasticity
timeFrame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
measure: Neurostimulation User Experience
timeFrame: End of intervention, an average of 4 weeks
measure: Overground Ambulation [as Appropriate to the Subject]
timeFrame: Baseline, 4 Weeks, 8 Weeks, and 20 Weeks
measure: Trunk Stability
timeFrame: Beginning of intervention to end of intervention, an average of 17 days, 8 weeks post beginning of intervention, 20 weeks post beginning of intervention; change from beginning of intervention at week 20 reported.
measure: Neurostimulator Lead Location and Migration [Epidural Group Only]
timeFrame: Pre-intervention and 4 weeks post-intervention
measure: Bladder Function Testing
timeFrame: Beginning of study, prior to initiating intervention; End of 4 weeks of intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kristin D Zhao, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: