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Clinical Trials/NCT07619300
NCT07619300Not yet recruitingNot Applicable

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

Peter J. Grahn, Ph.D.1 site in 1 country1 target enrollmentStarted: December 1, 2026Last updated:
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Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
1
Locations
1
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Dorsal Root Ganglion Stimulation

Experimental

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

Intervention: Abbot Dorsal Root Ganglion Neurostimulator (Device)

Investigators

Sponsor
Peter J. Grahn, Ph.D.
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Peter J. Grahn, Ph.D.

Principal Investigator

Mayo Clinic

Study Sites (1)

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