Restoration of Standing and Walking With ISMS in Humans

NCT02899858 | Withdrawn DMC

• 1 other identifier: 140503
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Thoracic spinal cord injury; Paralysis; ASIA A; Device

Outcome Measures

Primary Outcomes (1)

• IntraSpinal Micro-Stimulation

  Movement of either or both lower extremities while the subject is anesthetized during routine spinal surgery will be performed.

  3 years

Secondary Outcomes (1)

• ISMS data collection:

  3 years

Other Outcomes (1)

• ISMS data review

  3 years

Study Arms (1)

IntraSpinal Micro-Stimulation

EXPERIMENTAL

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: Movement Assessment; Other: MRI Scan; Procedure: IntraSpinal Micro-Stimulation; Other: Follow up clinical exam; Other: Post Op MRI Scan; Other: Follow up gait assessment

Interventions

Movement Assessment OTHER

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

IntraSpinal Micro-Stimulation

MRI Scan OTHER

Total MRI of spine to evaluate condition of spinal cord

IntraSpinal Micro-Stimulation

IntraSpinal Micro-Stimulation PROCEDURE

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)

IntraSpinal Micro-Stimulation

Follow up clinical exam OTHER

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

IntraSpinal Micro-Stimulation

Post Op MRI Scan OTHER

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

IntraSpinal Micro-Stimulation

Follow up gait assessment OTHER

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

IntraSpinal Micro-Stimulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-50 years old; male or female (no preference).
• Complete paraplegia (ASIA A classification) as a result of a spinal cord injury between the levels of T2-8.
• i. No motor or sensory function below the level of injury as determined by a physician.
• ii. No voluntary bladder function - defined as the inability to sense bladder fullness or voluntary contraction of the bladder (meets criteria for no sacral sparing).
• iii. Stable paraplegia.
• Patients with involuntary spasms are allowed. However, spasticity must be less than Ashworth 4 or spasm rating of 3 or less.
• History of spinal cord injury greater than 1 year.
• Intent to undergo spine surgery involving exposure of at least T9-T12 vertebral lamina.
• MRI studies performed within the past year showing presence of spinal cord between T8-L1 with reasonable normal anatomical shape. No chronic infections.
• Ability to travel to Vanderbilt Medical Center.

You may not qualify if:

• Acute medical conditions that are under active treatment. Examples include active urinary tract infection, respiratory illness, decubital ulcers, fractures, upper extremity injury, back pain.
• Pregnancy.
• Presence of a neurostimulator, bladder stimulator, cardiac stimulator or other electrical stimulator device implant.
• Inability to transfer from wheel chair to chair or bed.
• Inability to tolerate 1 hour of physical activity such as gait training in a harness.
• Severe depression requiring active medical treatment or counseling.
• Cognitive impairment that places the study volunteer under the 6th grade reading level.
• Inability to provide consent.
• Intradural or extradural masses compressing or displacing the spinal cord between T8-L1 region.
• Significant change in motor or sensory function over the previous year.
• History of spinal cord injury less than 1 year.
• Previous laminectomy and intradural spinal cord procedure involving the region of T9-T12.
• Patients with involuntary spasms with rigidity more than Ashworth 4 or spasm rating of 3 or more.

Sponsors & Collaborators

• Vanderbilt University: lead
• University of Alberta: collaborator
• Belmont University: collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

• Mushahwar VK, Jacobs PL, Normann RA, Triolo RJ, Kleitman N. New functional electrical stimulation approaches to standing and walking. J Neural Eng. 2007 Sep;4(3):S181-97. doi: 10.1088/1741-2560/4/3/S05. Epub 2007 Aug 22.

  PMID: 17873417 BACKGROUND

• Bamford JA, Mushahwar VK. Intraspinal microstimulation for the recovery of function following spinal cord injury. Prog Brain Res. 2011;194:227-39. doi: 10.1016/B978-0-444-53815-4.00004-2.

  PMID: 21867807 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Paralysis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Peter Konrad, MD PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 14, 2016
• Study Start: January 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: February 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 1 year of closure of study
• Access Criteria: Written report of protocol shared with sponsoring agency - US Army.

Locations

US (1)