Restoration of Standing and Walking With ISMS in Humans

Summary

Spinal cord neural circuitry exists in the lumbar enlargement that makes it possible to stand and create synergistic, rhythmic stepping activity in the lower limbs. In the past 20 years, clinicians have tried to reengage such these circuits for standing and walking in the lower spinal cord of paralyzed humans through novel paradigms of physical therapy, pharmacological stimulation of the spinal cord, or recently - epidural stimulation of the spinal cord. Although standing and stepping with these maneuvers are rudimentary at best, these human studies offer promise to restore controlled, lower extremity movement to the spinal cord injured (SCI) individual. Evidence from animal data suggests that more focal activation of intraspinal circuitry (IntraSpinal Micro-Stimulation - ISMS) would produce more fatigue resistant, natural standing and stepping activity in humans. To date, there has been no direct confirmation of such circuitry in the spinal cord of bipedal humans who have been paralyzed. Furthermore, mapping of such circuitry would provide the basis of a novel intraspinal neuroprosthetic that should be able to restore control of standing or walking in a manner that is much more physiologically normal and tolerable than by stimulating each individual muscle group. Proof of the existence of these spinal circuits in man, and the ability to activate and control these circuits by first mapping the spinal cord is the basis of this proposal.

Conditions

• Spinal Cord Injury
• Paralysis

Interventions

OTHER

Movement Assessment

Documentation of ASIA A (T2-8) status at Belmont Gait Lab

OTHER

MRI Scan

Total MRI of spine to evaluate condition of spinal cord

PROCEDURE

IntraSpinal Micro-Stimulation

IntraSpinal Micro-Stimulation will be performed using a maximum of 16 electrodes inserted along each side of spinal cord that correlate with movements created across all 3 joints (hips, knees, and ankles)

OTHER

Follow up clinical exam

All subjects will be expected to return for a follow-up visit with Drs. Konrad at 1, 3 and 6 month follow up visits.

OTHER

Post Op MRI Scan

An MRI will be obtained at 3 months following the procedure to document the impact of the mapping procedure on spinal cord anatomy.

OTHER

Follow up gait assessment

Follow-up assessment with the Belmont Gait Lab will be performed at the 6 month follow up visit

Sponsors & Collaborators

• University of Alberta

  collaborator OTHER

• Belmont University

  collaborator OTHER

• Vanderbilt University

  lead OTHER

Principal Investigators

• Peter Konrad, MD PhD · Vanderbilt University Medical Center

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2019-10-31

Completion

2019-10-31

Countries

• United States

Study Locations