Dorsal Root Ganglion Stimulation After Lower Motor Neuron Damage

Peter J. Grahn, Ph.D.

Status: Begins enrollment this month

Conditions: Spinal Cord Injuries; Lower Motor Neuron Disease

Treatments: Device: Abbot Dorsal Root Ganglion Neurostimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT07619300

26-003033

Details and patient eligibility

About

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.

Enrollment: 1 estimated patient

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Dorsal Root Ganglion Stimulation

Experimental group

Description:

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

Treatment:

Device: Abbot Dorsal Root Ganglion Neurostimulator