Clinical trial NCT04736849: Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury
Official title: Pilot Study of Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Paraplegia
Tetraplegia
Paralysis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 22
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: This study aims to expand the understanding of how electrical spinal stimulation enables function, specifically the pathophysiological mechanisms of action underlying spinal electrical stimulation after SCI, and to address the gap in knowledge of spinal sensorimotor network inputs and outputs generated by spinal electrical stimulation in humans with SCI.

Eligibility criteria: Inclusion Criteria:

* Spinal cord injury due to trauma located at or above 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

Exclusion Criteria:

* Currently a prison inmate, or awaiting trial, related to criminal activity
* Pregnancy at the time of screening for trial enrollment
* Active, untreated urinary tract infection
* 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
* Non-MRI-compatible implanted medical devices
* Other implanted stimulation devices (e.g. deep brain stimulator, cardiac pacemaker, diaphragmatic pacer, etc.)
* 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

Primary outcomes:
measure: Kinematics
timeFrame: Rehabilitation Day 1, Rehabilitation Day 10
measure: Electromyography
timeFrame: Rehabilitation Day 1, Rehabilitation Day 10
measure: Electroneurography
timeFrame: Rehabilitation Day 1, Rehabilitation Day 10
measure: Foot pressure
timeFrame: Rehabilitation Day 1, Rehabilitation Day 10
measure: Seated pressure
timeFrame: Through study completion, an average of 4 weeks
measure: Somatosensory evoked potentials
timeFrame: Through study completion, an average of 4 weeks
measure: Transcranial magnetic stimulation motor evoked potentials
timeFrame: Through study completion, an average of 4 weeks
measure: Injury severity: American Spinal Injury Association Impairment Scale (AIS)
timeFrame: Through study completion, an average of 4 weeks
measure: Patient-reported bowel function
timeFrame: Through study completion, an average of 4 weeks
measure: Patient-reported bladder function
timeFrame: Through study completion, an average of 4 weeks
measure: Male patient-reported sexual function (1)
timeFrame: Through study completion, an average of 4 weeks
measure: Male patient-reported sexual function (2)
timeFrame: Through study completion, an average of 4 weeks
measure: Female patient-reported sexual function
timeFrame: Through study completion, an average of 4 weeks
measure: Spasticity
timeFrame: Through study completion, an average of 4 weeks
measure: Neurostimulation user experience
timeFrame: At study completion, an average of 4 weeks
measure: Overground ambulation [as appropriate to the subject] (1)
timeFrame: Through study completion, an average of 4 weeks
measure: Overground ambulation [as appropriate to the subject] (2)
timeFrame: Through study completion, an average of 4 weeks
measure: Balance [as appropriate to the subject] (2)
timeFrame: Through study completion, an average of 4 weeks
measure: Balance (1)
timeFrame: Through study completion, an average of 4 weeks
measure: Exertion
timeFrame: Through study completion, an average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Peter J. Grahn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: