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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dorsal Root Ganglion Stimulation | Experimental | One adult patient with spinal cord injury below T10 will be treated with dorsal root ganglion stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abbot Dorsal Root Ganglion Neurostimulator | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change America Spinal Injury Association (ASIA) Impairment Scale categorization | 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. | Baseline, 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neurogenic Bladder Symptom (NBSS) score | 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. | Baseline, 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter J. Grahn, Ph.D. | Contact | 507-316-5556 | grahn.peter@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Peter J. Grahn, Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D016472 | Motor Neuron Disease |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Change in Neurogenic Bowel Dysfunction Survey (NBD) score | 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. | Baseline, 14 days |
| Change in sexual function survey score | 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. | Baseline, 14 days |
| D014947 | Wounds and Injuries |
| D019636 | Neurodegenerative Diseases |
| D009468 | Neuromuscular Diseases |