Clinical trial NCT04627441: Transcutaneous and Epidural Stimulation in SCI
Official title: A Pilot Study of the Characterization of Transcutaneous and Epidural Spinal Stimulation for Enabling Motor Function in Humans With Motor Complete Paraplegia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Paraplegia, Spinal
Paraplegia, Complete
Paraplegia; Traumatic
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study seeks to improve the scientific understanding of how two electrical stimulation techniques, one which delivers electricity to the skin surface over the spine (transcutaneous electrical spinal stimulation \[TESS\]) and another which is implanted onto the dura mater of the spinal cord (epidural electrical stimulation \[EES\]), facilitate spinal circuitry to enable function after SCI.

Detailed description: The study will compare motor activity and clinical outcomes over the course of TESS and EES in combination with physical rehabilitation.

The primary outcome data collected will be used to characterize and compare spinal sensorimotor activity in muscles below the level of injury during TESS and EES-enabled motor tasks in persons with chronic motor complete paralysis of the lower extremities due to traumatic SCI. Furthermore, data collected will be used as a proof of concept that TESS can be used to determine recovery of function during EES-enabled motor tasks. Following exposure to each stimulation intervention, data collection will include changes to spasticity, body composition, metabolic variables, and spinal imaging to assess the effect of either TESS or EES stimulation.

Eligibility criteria: Inclusion Criteria:

* Spinal cord injury due to trauma located between the seventh cervical (C7) and tenth thoracic vertebrae (T10)
* American Spinal Injury Association grading scale of A or B (4 each of A and B) 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
* Dual energy x-ray absorptiometry (DEXA) t-score \<-3.5 at spine and femur head
* History of chronic and/or treatment resistant urinary tract infection
* Unhealed decubitus ulcer
* Unhealed skeletal fracture
* Untreated clinical diagnosis of depression
* Presence of joint contractures or an Ashworth spasticity score of 4
* Active anti-spasticity medication regimen within 3 months prior to study enrollment
* Presence of transcranial magnetic stimulation-evoked potentials in leg muscles
* 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
* Mass \> 113 kg (250 pounds)
* 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: Kinematics
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Electromyography
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Foot pressure
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Overground ambulation [as appropriate to the subject] (1)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Overground ambulation [as appropriate to the subject] (2)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Somatosensory evoked potentials
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Transcranial magnetic stimulation motor evoked potentials
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Monosynaptic spinal reflex testing
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Trunk stability
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Injury severity: American Spinal Injury Association (ASIA) Impairment Scale
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
Secondary outcomes:
measure: Spasticity
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Bone mineral density
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Body composition - body fat mass
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Body composition - lean mass
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Body composition - android and gynoid fat percentage
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Body composition - bone mass
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Metabolics - CBC
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Metabolics - glucose
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Metabolics - total cholesterol
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Metabolics - HDL cholesterol
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Metabolics - calculated LDL cholesterol
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Metabolics - triglycerides
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Metabolics - non-HDL cholesterol
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Neurostimulator array location and migration
timeFrame: Start of EES, End month 6 EES
measure: Patient-reported bowel function (1)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Patient-reported bowel function (2)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Patient-reported bladder function (1)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Patient-reported bladder function (2)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Male patient-reported sexual function (1)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Male patient-reported sexual function (2)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Male patient-reported sexual function (3)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Female patient-reported sexual function (1)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Female patient-reported sexual function (2)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
Other outcomes:
measure: Volitional movement (1)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Volitional movement (2)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Volitional movement (3)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Volitional movement (4)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Volitional movement (5)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Volitional movement (6)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Volitional movement (7)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Volitional movement (8)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Overground ambulation [as appropriate to the subject] (1)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Overground ambulation [as appropriate to the subject] (2)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
measure: Overground ambulation [as appropriate to the subject] (3)
timeFrame: Baseline, End of TESS, Start of EES, End month 6 EES
Locations:
Study officials:
affiliation: Mayo Clinic
name: Kristin D. Zhao, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: