A Study of Transcutaneous and Epidural Spinal Stimulation for Enabling Motor Function in Humans with Motor Complete Paraplegia
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 18-011086
NCT ID: NCT03945331
Sponsor Protocol Number: 18-011086
About this study
The purpose of this study is to characterize and compare sensorimotor activity in muscles below the level of injury during Transcutaneous Epidural Spinal Stimulation (TESS) and Epidural Electrical Stimulation (EES)-enabled motor tasks, and to assess and compare changes in clinical outcomes over the course of rehabilitation with TESS and EES.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- 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.
- 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 interventionalclinical 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Kristin Zhao, Ph.D., M.S.
Closed for enrollment
Publications are currently not available