Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury

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Brief Title

Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury

Official Title

Pilot Study of Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury

Brief Summary

      A study to compare electrophysiologic activity of epidural stimulation and dorsal root
      ganglion stimulation, as well as quantify changes in motor performance with both types of
      stimulation over the course of 10 rehabilitation sessions.
    

Detailed Description

      This study aims to expand the understanding of how electrical spinal stimulation enables
      function, specifically the pathophysiological mechanisms of action underlying spinal
      electrical stimulation after SCI, and to address the gap in knowledge of spinal sensorimotor
      network inputs and outputs generated by spinal electrical stimulation in humans with SCI.
    


Study Type

Interventional


Primary Outcome

Kinematics


Condition

Spinal Cord Injuries

Intervention

Percutaneous epidural and dorsal root stimulation

Study Arms / Comparison Groups

 Percutaneous ES and DRS
Description:  Epidural Stimulation (ES) and Dorsal Root Stimulation (DRS) will be delivered via percutaneously implanted electrodes during rehabilitation. All implanted electrodes will be removed at the end of trial participation. The effects of ES and DRS will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

32

Start Date

September 24, 2021

Completion Date

October 31, 2025

Primary Completion Date

October 31, 2025

Eligibility Criteria

        Inclusion Criteria:

          -  Spinal cord injury due to trauma located between the seventh cervical vertebrae and
             the tenth thoracic vertebrae

          -  American Spinal Injury Association grading scale of A, B, C, or D

          -  Intact spinal reflexes below the level of SCI

          -  SCI must have occurred at least 1 year prior to study enrollment

          -  At least 22 years of age

          -  If female, must be willing to use medically-acceptable method of contraception during
             study participation

          -  Completed vaccination series for SARS-CoV-2

        Exclusion Criteria:

          -  Currently a prison inmate, or awaiting trial, related to criminal activity

          -  Pregnancy at the time of screening for trial enrollment

          -  DEXA (dual-energy x-ray absorptiometry) T-score of less than -3.5 at spine and femur
             head

          -  Active, untreated urinary tract infection

          -  Body mass > 113 kg (250 pounds)

          -  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

          -  Modified Ashworth Spasticity score of 4 during impaired joint assessments

          -  Non-MRI-compatible implanted medical devices

          -  Undergoing, or planning to undergo, diathermy treatment

          -  Active participation in an interventional clinical trial

          -  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
      

Gender

All

Ages

22 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Peter J. Grahn, Ph.D., 507-538-1016, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04736849

Organization ID

20-006104


Responsible Party

Sponsor-Investigator

Study Sponsor

Peter J. Grahn, Ph.D.


Study Sponsor

Peter J. Grahn, Ph.D., Principal Investigator, Mayo Clinic


Verification Date

October 2021