ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02899858
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
University of Alberta
Belmont University
Information provided by (Responsible Party):
Peter Konrad, Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Paralysis 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 Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Restoration of Standing and Walking With ISMS in Humans
Study Start Date : January 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

Arm Intervention/treatment
Experimental: 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: 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




Primary Outcome Measures :
  1. IntraSpinal Micro-Stimulation [ Time Frame: 3 years ]
    Movement of either or both lower extremities while the subject is anesthetized during routine spinal surgery will be performed.


Secondary Outcome Measures :
  1. ISMS data collection: [ Time Frame: 3 years ]
    Kinesiology measurement data collected from Dr. Robinson's Gait lab preoperatively will be compared with intraoperative movement data.


Other Outcome Measures:
  1. ISMS data review [ Time Frame: 3 years ]
    Human data collected in this study will be compared with pre-clinical animal data from U Alberta, Canada by Dr. Mushahwar's team.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-50 years old; male or female (no preference).
  2. 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.

  3. Patients with involuntary spasms are allowed. However, spasticity must be less than Ashworth 4 or spasm rating of 3 or less.
  4. History of spinal cord injury greater than 1 year.
  5. Intent to undergo spine surgery involving exposure of at least T9-T12 vertebral lamina.
  6. MRI studies performed within the past year showing presence of spinal cord between T8-L1 with reasonable normal anatomical shape. No chronic infections.
  7. Ability to travel to Vanderbilt Medical Center.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899858


Contacts
Contact: Peter E Konrad, MD, PHD 615-343-9822 peter.konrad@vanderbilt.edu
Contact: Melba Isom, ASB,CCPR 615-875-5853 melba.isom@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Peter E Konrad, MD, Ph.D.    615-343-9822    peter.konrad@vanderbilt.edu   
Contact: Melba T Isom    615-343-9822    melba.isom@vanderbilt.edu   
Principal Investigator: Peter E Konrad, MD, Ph.D.         
Sponsors and Collaborators
Vanderbilt University
University of Alberta
Belmont University

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 140503

Publications:
Responsible Party: Peter Konrad, MD, PhD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02899858     History of Changes
Other Study ID Numbers: 140503
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with the DSMB when screening and recruiting subjects and when a subject exits the study

Keywords provided by Peter Konrad, Vanderbilt University:
Thoracic spinal cord injury
Paralysis
ASIA A
Device

Additional relevant MeSH terms:
Spinal Cord Injuries
Paralysis
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurologic Manifestations
Signs and Symptoms