Lower Motor Neuron Disease, Spinal Cord Injuries
Conditions
Brief summary
The purpose of this study is to study sensorimotor circuit activity generated in response to temporarily implanted dorsal root ganglion stimulation by recording from muscles of the lower extremities as well as functional outcomes achieved over a 10-day rehabilitation program in an individual with lower motor neuron injury.
Interventions
DEVICEAbbot Dorsal Root Ganglion Neurostimulator
After temporary implantation of leads into the dorsal root ganglia of lower spine, the patient will undergo 2-3 hour sessions over 10 days. Each session will consist of rehabilitation exercises will receiving electrical spinal stimulation.
Sponsors
Peter J. Grahn, Ph.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Traumatic and non-traumatic spinal cord injury (SCI) * ASIA Impairment Scale (AIS) A-D * SCI below the tenth thoracic vertebral level * Greater than 1 year post-SCI * Intact spinal reflexes at or below injury level in 1 or more muscles
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.) * Active participation in an interventional clinical trial which, based on the research team's assessment, may compromise protocol compliance, safety, and/or validity of data collected during this study * 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 |
|---|---|---|
| Change America Spinal Injury Association (ASIA) Impairment Scale categorization | Baseline, 14 days | The America Spinal Injury Association Impairment Scale is a provider assessment that categorizes spinal cord injuries into five distinct classifications, each representing different degrees of neurological impairment and functional preservation. Categories are defined as Grade A: complete impairment; Grade B: sensory but not motor function preserved; Grade C: motor function incomplete (most muscles): Grade D: motor function incomplete (half of key muscles); and Grade E: normal sensory and motor functions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Neurogenic Bladder Symptom (NBSS) score | Baseline, 14 days | The Neurogenic Bladder Symptom Score (NBSS) survey a 24-item validated instrument that incorporates questions on bladder management, incontinence, storage, voiding and consequences and the impact on quality of life. Total scores range from 0 - 74, with higher scores indicating more severe bladder symptoms and dysfunction. |
| Change in Neurogenic Bowel Dysfunction Survey (NBD) score | Baseline, 14 days | The Neurogenic Bowel Dysfunction Survey (NBD) a validated questionnaire that incorporates several questions regarding fecal incontinence, constipation, obstruction, and impact on quality of life. Each of the 10 items on the NBD is weighted according to its importance on quality of life. Total scores range from 0 -47, with higher scores indicating more severe bowel dysfunction. |
| Change in sexual function survey score | Baseline, 14 days | International spinal cord injury female sexual and reproductive function basic data set (version 2.0) or International spinal cord injury male sexual function basic data set (version 2.0) will be used depending on subject enrolled. The survey asks the participant to answer 4 questions regarding sexual dysfunction as related to spinal cord injury, with answers on a scale of 0 = normal, 1 = reduced or altered, and 2 = absent. Higher scores indicate a greater level of impairment. |
Countries
United States
Contacts
CONTACTPeter J. Grahn, Ph.D.
PRINCIPAL_INVESTIGATORPeter J. Grahn, Ph.D.
Mayo Clinic
Outcome results
None listed