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Not yet recruiting NCT07619300

Dorsal Root Ganglion Stimulation After Lower Motor Neuron Damage

No phase Interventional Spinal Cord Injuries Lower Motor Neuron Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Abbot Dorsal Root Ganglion Neurostimulator.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries, Lower Motor Neuron Disease. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Pilot Study: Dorsal Root Ganglion Stimulation After Spinal Cord Injury-Related Lower Motor Neuron Damage

Overview

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

  • Device Abbot 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.

Primary outcome measures

  • Change America Spinal Injury Association (ASIA) Impairment Scale categorization [Time frame: Baseline, 14 days]
Secondary outcome measures (3)
  • Change in Neurogenic Bladder Symptom (NBSS) score [Time frame: Baseline, 14 days]
  • Change in Neurogenic Bowel Dysfunction Survey (NBD) score [Time frame: Baseline, 14 days]
  • Change in sexual function survey score [Time frame: Baseline, 14 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT07619300 · 26-003033

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗