Epidural and Dorsal Root Stimulation in Humans with Spinal Cord Injury

Overview

Información sobre este estudio

A study to compare electrophysiologic activity of epidural stimulation and dorsal root ganglion stimulation, as well as quantify changes in motor performance with both types of stimulation over the course of 10 rehabilitation sessions.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

- Spinal cord injury due to trauma located between the seventh cervical vertebrae and
the tenth thoracic vertebrae

- American Spinal Injury Association grading scale of A, B, C, or D

- Intact spinal reflexes below the level of SCI

- SCI must have occurred at least 1 year prior to study enrollment

- At least 22 years of age

- If female, must be willing to use medically-acceptable method of contraception during
study participation

- Completed vaccination series for SARS-CoV-2

Exclusion Criteria:

- Currently a prison inmate, or awaiting trial, related to criminal activity

- Pregnancy at the time of screening for trial enrollment

- DEXA (dual-energy x-ray absorptiometry) T-score of less than -3.5 at spine and femur
head

- Active, untreated urinary tract infection

- Body mass > 113 kg (250 pounds)

- Unhealed decubitus ulcer

- Unhealed skeletal fracture

- Spinal abnormality that may impede percutaneous implantation of spinal electrodes

- Untreated clinical diagnosis of psychiatric disorder

- Joint contractures that impede typical range of motion

- Modified Ashworth Spasticity score of 4 during impaired joint assessments

- Non-MRI-compatible implanted medical devices

- Undergoing, or planning to undergo, diathermy treatment

- Active participation in an interventional clinical trial

- History of clinically-diagnosed cardiopulmonary disorder, such as severe orthostatic
hypotension, which may impede participation in rehabilitation activities such as
changes in body position such as supine-to-sit-to-stand activities, prolonged
standing, or stepping

- History of frequent and/or severe autonomic dysreflexia

- History of seizure disorder

- 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/20/22. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Peter Grahn, Ph.D.

Abierto para la inscripción

Contact information:

Tyson Scrabeck CCRP

(507) 538-1016

Scrabeck.Tyson@mayo.edu

More information

Publicaciones

Publications are currently not available