A Study of Transcutaneous and Epidural Spinal Stimulation for Enabling Motor Function in Humans with Motor Complete Paraplegia

Overview

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.

Participation eligibility

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. Please contact the study team to discuss whether or not you are eligible to participate in a study.

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 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 Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kristin Zhao, Ph.D.

Open for enrollment

Contact information:

Tyson Scrabeck CCRP

(507)538-1016

Scrabeck.Tyson@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20453423

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