Dorsal Root Ganglion Stimulation After Lower Motor Neuron Damage

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injuries; Lower Motor Neuron Disease
• Intervention / Treatment: Device: Abbot Dorsal Root Ganglion Neurostimulator

• Study Type: Interventional
• Enrollment (Estimated): 1
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter J. Grahn, Ph.D.; Phone Number: 507-316-5556; Email: grahn.peter@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
      • Contact: Peter J. Grahn, Ph.D.; Phone Number: 507-316-5556; Email: grahn.peter@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dorsal Root Ganglion Stimulation; One adult patient with spinal cord injury below T10 will be treated with dorsal root ganglion stimulation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Peter J. Grahn, Ph.D.
• Investigators: Principal Investigator: Peter J. Grahn, Ph.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Neurodegenerative Diseases; Trauma, Nervous System; Spinal Cord Diseases; Motor Neuron Disease; Spinal Cord Injuries
• Other Study ID Numbers: 26-003033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes