Dorsal Root Ganglion Stimulation After Lower Motor Neuron Damage

NCT07619300 | Not Yet Recruiting FDA Device

• 1 other identifier: 26-003033
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Lower Motor Neuron Disease

Outcome Measures

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.

  Baseline, 14 days

Secondary Outcomes (3)

• Change in Neurogenic Bladder Symptom (NBSS) score

  Baseline, 14 days

• Change in Neurogenic Bowel Dysfunction Survey (NBD) score

  Baseline, 14 days

• Change in sexual function survey score

  Baseline, 14 days

Study Arms (1)

Dorsal Root Ganglion Stimulation

EXPERIMENTAL

One adult patient with spinal cord injury below T10 will be treated with dorsal root ganglion stimulation.

Device: Abbot Dorsal Root Ganglion Neurostimulator

Interventions

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.

Dorsal Root Ganglion Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peter J. Grahn, Ph.D.: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Neuron Disease

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurodegenerative Diseases; Neuromuscular Diseases

Study Officials

• Peter J. Grahn, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter J. Grahn, Ph.D.

CONTACT

507-316-5556; grahn.peter@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 2, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)