Clinical trial NCT03945331: Transcutaneous and Epidural Spinal Stimulation for Enabling Motor Function in Humans With Motor Complete Paraplegia
Official title: Characterization of Transcutaneous and Epidural Spinal Stimulation for Enabling Motor Function in Humans With Motor Complete Paraplegia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Paraplegia, Spinal
Paraplegia, Complete
Paraplegia; Traumatic
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Minnesota Office of Higher Education
First posted: 2019-05-10
Enrollment: 2
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to compare transcutaneous electrical spinal stimulation (TESS) and epidural electrical stimulation (EES); in particular, the motor activity enabled by each method and the potential health benefits of each method.


Eligibility criteria: Inclusion Criteria

* Spinal cord injury due to trauma located between the seventh cervical and tenth thoracic vertebrae
* American Spinal Injury Association grading scale of A or B (at least 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
* 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
* Non MRI-compatible implanted medical devices.
* Undergoing, or planning to undergo, diathermy treatment
* Active participation in another interventional clinical trial
* Presence of conditions or disorders which require MRI monitoring
* For EES cohort subjects, 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, Month 3, Month 6, End of Month 7, Month 10, Month 13
measure: Electromyography
timeFrame: Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13
measure: Foot pressure
timeFrame: Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13
measure: Somatosensory evoked potentials
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Transcranial magnetic stimulation motor evoked potentials
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Monosynaptic spinal reflex testing
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Trunk stability
timeFrame: Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13
measure: Injury severity: American Spinal Injury Association Impairment Scale (AIS)
timeFrame: Baseline, Month 6, End of Month 7, Month 13
Secondary outcomes:
measure: Bowel function
timeFrame: Baseline, Month 6, Month 13
measure: Bladder function
timeFrame: Baseline, Month 6, Month 13
measure: Spasticity
timeFrame: Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13
measure: Bone mineral density
timeFrame: Baseline, Month 6, Month 13
measure: Body composition - body fat mass
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Body composition - lean mass
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Body composition - android and gynoid fat percentage
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Body composition - android and gynoid fat ratio
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Body composition - bone mass
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Knee cartilage health
timeFrame: Baseline, Month 6; Month 13 for TESS cohort only
measure: Metabolics - CBC
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Metabolics - glucose
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Metabolics - total cholesterol
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Metabolics - HDL cholesterol
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Metabolics - calculated LDL cholesterol
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Metabolics - triglycerides
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Metabolics - non-HDL cholesterol
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Spinal structural integrity
timeFrame: Baseline
measure: Injury severity and potential for spared tissue
timeFrame: Baseline
measure: Stimulator array location and migration (EES cohort only)
timeFrame: End of Month 7, Month 13
measure: Patient-reported bowel function (1)
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Patient-reported bowel function (2)
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Patient-reported bladder function (1)
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Patient-reported bladder function (2)
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Male patient-reported sexual function (1)
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Male patient-reported sexual function (2)
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Male patient-reported sexual function (3)
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Female patient-reported sexual function (1)
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Female patient-reported sexual function (2)
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Patient-reported quality of life (1): Spinal Cord Injury Secondary Conditions Scale (SCI-SCS)
timeFrame: Baseline, Month 6, End of Month 7, Month 13
measure: Patient-reported quality of life (2): World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)
timeFrame: Baseline, Month 6, End of Month 7, Month 13
Other outcomes:
measure: Volitional movement (1)
timeFrame: 1 year
measure: Volitional movement (2)
timeFrame: 1 year
measure: Volitional movement (3)
timeFrame: 1 year
measure: Volitional movement (4)
timeFrame: 1 year
measure: Volitional movement (5)
timeFrame: 1 year, for TESS cohort only
measure: Volitional movement (6)
timeFrame: 1 year
measure: Volitional movement (7)
timeFrame: 1 year
measure: Volitional movement (8)
timeFrame: 1 year
measure: Overground ambulation [as appropriate to the subject] (1)
timeFrame: 1 year
measure: Overground ambulation [as appropriate to the subject] (2)
timeFrame: 1 year
measure: Overground ambulation [as appropriate to the subject] (3)
timeFrame: 1 year
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: