Paralysis, Paraplegia, Spinal Cord Injuries, Tetraplegia
Conditions
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.
Interventions
DEVICEPercutaneous epidural and dorsal root stimulation
Abbott percutaneous trial lead for dorsal root ganglion neurostimulation (Model MN10350) Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Abbott clinician programmer for epidural and dorsal root ganglion neurostimulation (Model 3874) Ripple Neuromed Nomad Neurostimulation System
Sponsors
Peter J. Grahn, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electromyography | Assessed at Day 1 (beginning of intervention) and Day 10 (end of intervention). | Percent change in EMG voltage from beginning to end of intervention, recorded from the rectus femoris, during epidural and dorsal root spinal stimulation. |
| Foot Pressure | Assessed at Day 10 (end of intervention). | Measurements of foot pressure from shoe-insole sensors during no-stimulation bilaterally assisted standing and unassisted standing with stimulation. |
| Somatosensory Evoked Potentials | Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention). | Change from baseline to end of study, in amplitude of evoked potentials recorded from sensory cortex using skin surface electrodes during electrical stimulation of the right and left tibial nerve. |
| Transcranial Magnetic Stimulation Motor Evoked Potentials | Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention). | Change in intensity of stimulation, reported as percentage (0% to 100%) of maximum system output, required to elicit motor-evoked potentials below the level of injury. |
| American Spinal Injury Association Grading Scale | Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention). | Severity of spinal cord injury impairment will be assessed at baseline and end of study to examine changes in impairment that may be associated with the intervention. |
| Spasticity | Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention). | Change in measurements of spasticity using the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET). Answers to qualitative questions are rated from -3 to +3, with a higher positive number indicating more helpful symptoms, and a lower negative number indicating more problematic symptoms. Questions may also be answered as not applicable (N/A), which do not generate a score. Scores are totaled for a score which categorizes the overall positive or negative impact of a subject's spasticity symptoms. Total score can range from -105 (negative impact) to +105 (positive impact), and the score is averaged by total positive or negative score divided by the number of applicable answers. |
| Modified Functional Reach Test | Assessed at Day 10 (end of intervention). | On Day 10 (end of intervention), trunk balance was assessed with and without stimulation during attempts to reach forward using the modified functional reach test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Bowel Function | Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention). | Measurement of change in bowel function using the Neurogenic Bowel Dysfunction Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bowel symptoms. The total score ranges between 0 and 44 points. A higher total score indicates more severe bowel symptoms. |
| Patient-reported Bladder Function | Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention). | Measurement of change in bladder function using the Neurogenic Bladder Symptom Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bladder symptoms. The total score can range from 0 (no symptoms at all) to 74 (maximum symptoms). |
| Male Patient-reported Sexual Function (SHIM) | Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention). | Measurement of change in erectile dysfunction using the Sexual Health Inventory for Men (SHIM). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction. Total score can range from 1 to 25, with a lower number indicating more severe erectile dysfunction. |
| Male Patient-reported Sexual Function (IEF) | Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention). | Measurement of change in erectile dysfunction using the International Index for Erectile Function (IIEF). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction. Total scores range from 5 to 25, with a lower score indicating more severe erectile dysfunction. |
| Neurostimulation User Experience | Assessed at end of study ( after day 10 of intervention). | Rating of the subject's perception of individual aspects of spinal stimulation using the User Experience Questionnaire (UEQ), a survey including 26 descriptive terms and their antonyms. A scoring scale ranging from 1 to 7 determines how closely the subject feels the term or its antonym applies to the intervention, with lower numbers indicating agreement with the term, and higher numbers indicating agreement with the antonym. The terms and antonyms describe a positive and negative perception of each item. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPeter J. Grahn, Ph.D.
Mayo Clinic
Participant flow
Recruitment details
Participants were recruited from the following: * Mayo Clinic's volunteer research participant database * Mayo Clinic's clinical trials website * Mayo Clinic's electronic medical record database * ClinicalTrials.gov
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 4 |
| other Total, other adverse events | 12 / 18 | 4 / 4 |
| serious Total, serious adverse events | 0 / 18 | 1 / 4 |
Outcome results
None listed