Health TrialsbyHealthPanel

Dorsal Root Ganglion Stimulation After Lower Motor Neuron Damage

ConditionsSpinal Cord InjuriesLower Motor Neuron Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPeter J. Grahn, Ph.D.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

1 Participants
are divided into 1 treatment group
Group A: Dorsal Root Ganglion StimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 14 days

Secondary outcomes

1

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.

Time frame
Baseline, 14 days
2

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.

Time frame
Baseline, 14 days
3

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.

Time frame
Baseline, 14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peter J. Grahn, Ph.D.

Lead sponsor

Mayo Clinic

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: