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Restoration of Standing and Walking With ISMS in Humans (ISMS)

Primary Purpose

Spinal Cord Injury, Paralysis

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Movement Assessment

MRI Scan

IntraSpinal Micro-Stimulation

Follow up clinical exam

Post Op MRI Scan

Follow up gait assessment

About this trial

This is an interventional basic science trial for Spinal Cord Injury focused on measuring Thoracic spinal cord injury, Paralysis, ASIA A, Device

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Vanderbilt University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IntraSpinal Micro-Stimulation

Arm Description

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)

Outcomes

Primary Outcome Measures

IntraSpinal Micro-Stimulation

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

Secondary Outcome Measures

ISMS data collection:

Kinesiology measurement data collected from Dr. Robinson's Gait lab preoperatively will be compared with intraoperative movement data.

Full Information

NCT ID

NCT02899858

First Posted

August 26, 2016

Last Updated

February 7, 2022

Sponsor

Vanderbilt University

Collaborators

University of Alberta, Belmont University

1. Study Identification

Unique Protocol Identification Number

NCT02899858

Brief Title

Restoration of Standing and Walking With ISMS in Humans

Acronym

ISMS

Official Title

Restoration of Standing and Walking With ISMS in Humans

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Funding stopped and no one met IRB approved enrollment criteria

Study Start Date

January 2015 (Anticipated)

Primary Completion Date

October 2019 (Anticipated)

Study Completion Date

October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University

Collaborators

University of Alberta, Belmont University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Two study volunteers who are completely paralyzed (T2-8 region) to undergo an evaluation of ISMS during an otherwise normal thoracic spinal surgical procedure. The potential volunteers will be asked to review and sign a screening consent form prior to initial screening. This is to ensure that the ideal two patients are selected for this study and that foreseeable issues are identified and risks minimized for the volunteers. The subjects must have a stable, complete spinal cord injury involving their upper thoracic spinal cord (T2-8 region), and are otherwise planning to undergo a spine surgery involving the lower thoracic spinal cord. Subjects who have volunteered for this study will undergo their intended spinal surgery by the clinical team. The usual indications for undergoing such a surgery is either to correct a deformity involving the lower thoracic region, or stabilizing the lower thoracic region due to chronic instability from degenerative disease. The surgery intended for clinical treatment must involve exposure of the T9-T12 spinal lamina. However, exposure of the spinal cord through a dural opening would not normally be performed in this clinical scenario. The experimental portion of the surgery begins then, with a laminectomy of T9-T12 and exposure of the spinal cord through a durotomy using standard neurosurgical techniques for spinal cord exposure. The spinal cord in this region will then be mapped and stimulated using ISMS and the effects on the legs measured to determine if the circuitry exists to potentially allow standing or walking through the use of ISMS. The research requests subjects to specifically allow 2 hours of extra time during the routine spinal surgery to perform this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury, Paralysis

Keywords

Thoracic spinal cord injury, Paralysis, ASIA A, Device

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IntraSpinal Micro-Stimulation

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Movement Assessment

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

MRI Scan

Intervention Description

Total MRI of spine to evaluate condition of spinal cord

Intervention Type

Procedure

Intervention Name(s)

IntraSpinal Micro-Stimulation

Intervention Description

Intervention Type

Other

Intervention Name(s)

Follow up clinical exam

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Post Op MRI Scan

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Follow up gait assessment

Intervention Description

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

Primary Outcome Measure Information:

Title

IntraSpinal Micro-Stimulation

Description

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

Time Frame

3 years

Secondary Outcome Measure Information:

Title

ISMS data collection:

Description

Kinesiology measurement data collected from Dr. Robinson's Gait lab preoperatively will be compared with intraoperative movement data.

Time Frame

3 years

Other Pre-specified Outcome Measures:

Title

ISMS data review

Description

Human data collected in this study will be compared with pre-clinical animal data from U Alberta, Canada by Dr. Mushahwar's team.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Konrad, MD PhD

Organizational Affiliation

Vanderbilt University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data will be shared with the DSMB when screening and recruiting subjects and when a subject exits the study

IPD Sharing Time Frame

Within 1 year of closure of study

IPD Sharing Access Criteria

Written report of protocol shared with sponsoring agency - US Army.

Citations:

PubMed Identifier

17873417

Citation

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.

Results Reference

background

PubMed Identifier

21867807

Citation

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.

Results Reference

background

Available IPD and Supporting Information:

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www4.vanderbilt.edu/irb/

Available IPD/Information Identifier

140503

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Restoration of Standing and Walking With ISMS in Humans

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