Transcutaneous and Epidural Spinal Stimulation for Enabling Motor Function in Humans With Motor Complete Paraplegia (TransEpi)

Mayo Clinic

Status: Terminated

Conditions: Paraplegia; Traumatic; Paraplegia, Complete; Paraplegia, Spinal

Treatments: Device: Epidural spinal cord stimulation system; Device: Transcutaneous spinal cord stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT03945331

18-011086

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2 participants in 2 patient groups

TESS

Experimental group

Description:

Transcutaneous Electrical Spinal Stimulation (TESS), used during all training sessions.

Treatment:

Device: Transcutaneous spinal cord stimulator

EES

Experimental group

Description:

TESS, used during the initial 6-month training period, followed by Epidural Electrical Stimulation (EES) during the final 6-month training period.

Treatment:

Device: Transcutaneous spinal cord stimulator

Device: Epidural spinal cord stimulation system