Back to resultsSpinal Cord Injury Epidural Stimulation
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epidural Stimulator
Sponsored by
About this trial
This is an interventional device feasibility trial for Spinal Cord Injury
Eligibility Criteria
Inclusion Criteria:
- Stable medical condition without *cardiopulmonary disease or *dysautonomia that would contraindicate standing or stepping with body weight support training
- No current anti-spasticity medication regimen
- Non-progressive spinal cord injury between the vertebral levels of C7 & T10
- American Spinal Injury Association grading scale of A or B
- Sensory evoked potentials are either not present or have a bilateral delay
- Segmental reflexes remain functional below the lesion
- At least 2-years post-injury.
Exclusion Criteria:
- Pregnancy at time of enrollment
- Failure to obtain consent
- Prisoners
- Children (age less than 21)
- Any patient identified as unsuitable for this protocol by the Mayo study team
- Skeletal fracture
- Osteoporosis with Dual-energy X-ray absorptiometry (DEXA) t score ≤-3.5
- Uncontrolled urinary tract infections
- Presence or history of frequent decubitus ulcers
- Clinical depression
- Drug abuse
- Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training
- Current anti-spasticity medication regimen
- Voluntary motor response present in leg muscles
- Volitional control during voluntary movement attempts in leg muscles as measured by electromyography (EMG) activity
- Brain influence on spinal reflexes as measured by EMG activity
- Recordable motor evoked potential in the lower limbs with transcranial magnetic stimulation
- Implanted cardiac pacemaker
- Implanted defibrillator
- Other implanted metallic or active body worn medical electronic device such as an insulin pump
- *Cardiopulmonary disease that would result in exclusion from the study will be defined as clinically diagnosed chronic obstructive pulmonary disease, cardiac failure, and heart arrhythmia that would contraindicate sudden changes in body position such as sit-to-stand and stepping
- *Excessive and uncontrolled autonomic dysreflexia characterized by symptomatic hypotension, light headedness and hypertension, flushing and bradycardia. Additionally blood pressure monitoring will be available at all times during rehabilitation and assessment times.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active stimulation
Arm Description
Subjects will be implanted with an epidural stimulator onto the dorsal aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program of daily physical rehabilitation, treadmill step training, and epidural stimulation to recover motor, sensory, and autonomic function. The total estimated time for the intervention is 66 weeks.
Outcomes
Primary Outcome Measures
Duration of time for which subject can sit unassisted on the edge of a mat table
Assessment of volitional movement of lower limbs
Subject's ability to coordinate stepping on a treadmill will be measured using biomechanical and electrophysiological analyses
Duration of time for which subject can stand weight bearing with minimal assistance provided as needed.
Secondary Outcome Measures
Change in volitional movement restoration via NeuroRecovery scale
Change of bladder function, as measured by the Neurogenic Bladder Symptom Score questionnaire
Change in sexual function as measured by the Sexual Function Questionnaire
Change in body thermoregulatory capacity as measured by thermoregulatory sweat testing
Change in lean body mass
Change in bone density
Change in sense of wellbeing as measured by the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire
Change in sitting balance via functional reach test
Change in spasticity via Ashworth spasticity test
Change in ability of performing basic activities of daily life via spinal cord independence measure
Change in total body fat
Change in bowel function as measured by the Neurogenic Bowel Dysfunction Score questionnaire
Full Information
NCT ID
NCT02592668
First Posted
October 22, 2015
Last Updated
April 9, 2020
Sponsor
Mayo Clinic
Collaborators
University of California, Los Angeles, Reneu Health Inc., Bel13ve in Miracles Foundation, The Craig H. Neilsen Foundation, National Center for Advancing Translational Sciences (NCATS)
1. Study Identification
Unique Protocol Identification Number
NCT02592668
Brief Title
Spinal Cord Injury Epidural Stimulation
Official Title
A Feasibility Study: Epidural Stimulation to Enable Volitional Movement After Chronic Complete Paralysis in Humans.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 4, 2016 (Actual)
Primary Completion Date
September 14, 2018 (Actual)
Study Completion Date
February 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
University of California, Los Angeles, Reneu Health Inc., Bel13ve in Miracles Foundation, The Craig H. Neilsen Foundation, National Center for Advancing Translational Sciences (NCATS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a feasibility study to test the use of epidural stimulation to restore volitional function previously lost due to spinal cord injury.
Previous studies conducted in animal models, performed elsewhere and here at Mayo Clinic, have shown that direct electrical stimulation of the spinal cord increases the excitability of spared neuronal connections within the site of injury, thereby enhancing signal transmission and allowing recovery of previously lost volitional function. Recently, epidural electrical stimulation of the lumbosacral spinal cord in four individuals with spinal cord injury (SCI) has restored motor and autonomic function below the level of injury. Despite positive results, further translational research is needed to validate these findings. The goal of this proposal is to perform epidural stimulation to restore volitional function in patients with SCI. In two patients, we will implant an epidural stimulator onto the dorsal aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program of daily physical rehabilitation, treadmill step training, and epidural stimulation to recover motor, sensory, and autonomic function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active stimulation
Arm Type
Experimental
Arm Description
Subjects will be implanted with an epidural stimulator onto the dorsal aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program of daily physical rehabilitation, treadmill step training, and epidural stimulation to recover motor, sensory, and autonomic function. The total estimated time for the intervention is 66 weeks.
Intervention Type
Device
Intervention Name(s)
Epidural Stimulator
Other Intervention Name(s)
Medtronic Restore ULTRA 97712
Intervention Description
Subjects will be implanted with an epidural stimulator onto the dorsal aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program of daily physical rehabilitation, treadmill step training, and epidural stimulation to recover motor, sensory, and autonomic function.
Primary Outcome Measure Information:
Title
Duration of time for which subject can sit unassisted on the edge of a mat table
Time Frame
Approximately 50 weeks after implantation
Title
Assessment of volitional movement of lower limbs
Time Frame
Approximately 50 weeks after implantation
Title
Subject's ability to coordinate stepping on a treadmill will be measured using biomechanical and electrophysiological analyses
Time Frame
Approximately 50 weeks after implantation
Title
Duration of time for which subject can stand weight bearing with minimal assistance provided as needed.
Time Frame
Approximately 50 weeks after implantation
Secondary Outcome Measure Information:
Title
Change in volitional movement restoration via NeuroRecovery scale
Time Frame
baseline, approximately 50 weeks after implantation
Title
Change of bladder function, as measured by the Neurogenic Bladder Symptom Score questionnaire
Time Frame
baseline, approximately 50 weeks after implantation
Title
Change in sexual function as measured by the Sexual Function Questionnaire
Time Frame
baseline, approximately 50 weeks after implantation
Title
Change in body thermoregulatory capacity as measured by thermoregulatory sweat testing
Time Frame
baseline, approximately 50 weeks after implantation
Title
Change in lean body mass
Time Frame
baseline, approximately 50 weeks after implantation
Title
Change in bone density
Time Frame
baseline, approximately 50 weeks after implantation
Title
Change in sense of wellbeing as measured by the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire
Time Frame
baseline, approximately 50 weeks after implantation
Title
Change in sitting balance via functional reach test
Time Frame
baseline, approximately 50 weeks after implantation
Title
Change in spasticity via Ashworth spasticity test
Time Frame
baseline, approximately 50 weeks after implantation
Title
Change in ability of performing basic activities of daily life via spinal cord independence measure
Time Frame
baseline, approximately 50 weeks after implantation
Title
Change in total body fat
Time Frame
baseline, approximately 50 weeks after implantation
Title
Change in bowel function as measured by the Neurogenic Bowel Dysfunction Score questionnaire
Time Frame
baseline, approximately 50 weeks after implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stable medical condition without *cardiopulmonary disease or *dysautonomia that would contraindicate standing or stepping with body weight support training
No current anti-spasticity medication regimen
Non-progressive spinal cord injury between the vertebral levels of C7 & T10
American Spinal Injury Association grading scale of A or B
Sensory evoked potentials are either not present or have a bilateral delay
Segmental reflexes remain functional below the lesion
At least 2-years post-injury.
Exclusion Criteria:
Pregnancy at time of enrollment
Failure to obtain consent
Prisoners
Children (age less than 21)
Any patient identified as unsuitable for this protocol by the Mayo study team
Skeletal fracture
Osteoporosis with Dual-energy X-ray absorptiometry (DEXA) t score ≤-3.5
Uncontrolled urinary tract infections
Presence or history of frequent decubitus ulcers
Clinical depression
Drug abuse
Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training
Current anti-spasticity medication regimen
Voluntary motor response present in leg muscles
Volitional control during voluntary movement attempts in leg muscles as measured by electromyography (EMG) activity
Brain influence on spinal reflexes as measured by EMG activity
Recordable motor evoked potential in the lower limbs with transcranial magnetic stimulation
Implanted cardiac pacemaker
Implanted defibrillator
Other implanted metallic or active body worn medical electronic device such as an insulin pump
*Cardiopulmonary disease that would result in exclusion from the study will be defined as clinically diagnosed chronic obstructive pulmonary disease, cardiac failure, and heart arrhythmia that would contraindicate sudden changes in body position such as sit-to-stand and stepping
*Excessive and uncontrolled autonomic dysreflexia characterized by symptomatic hypotension, light headedness and hypertension, flushing and bradycardia. Additionally blood pressure monitoring will be available at all times during rehabilitation and assessment times.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin D. Zhao, Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28385196
Citation
Grahn PJ, Lavrov IA, Sayenko DG, Van Straaten MG, Gill ML, Strommen JA, Calvert JS, Drubach DI, Beck LA, Linde MB, Thoreson AR, Lopez C, Mendez AA, Gad PN, Gerasimenko YP, Edgerton VR, Zhao KD, Lee KH. Enabling Task-Specific Volitional Motor Functions via Spinal Cord Neuromodulation in a Human With Paraplegia. Mayo Clin Proc. 2017 Apr;92(4):544-554. doi: 10.1016/j.mayocp.2017.02.014.
Results Reference
background
PubMed Identifier
30250140
Citation
Gill ML, Grahn PJ, Calvert JS, Linde MB, Lavrov IA, Strommen JA, Beck LA, Sayenko DG, Van Straaten MG, Drubach DI, Veith DD, Thoreson AR, Lopez C, Gerasimenko YP, Edgerton VR, Lee KH, Zhao KD. Neuromodulation of lumbosacral spinal networks enables independent stepping after complete paraplegia. Nat Med. 2018 Nov;24(11):1677-1682. doi: 10.1038/s41591-018-0175-7. Epub 2018 Sep 24. Erratum In: Nat Med. 2018 Oct 23;:
Results Reference
background
PubMed Identifier
30430902
Citation
Calvert JS, Grahn PJ, Strommen JA, Lavrov IA, Beck LA, Gill ML, Linde MB, Brown DA, Van Straaten MG, Veith DD, Lopez C, Sayenko DG, Gerasimenko YP, Edgerton VR, Zhao KD, Lee KH. Electrophysiological Guidance of Epidural Electrode Array Implantation over the Human Lumbosacral Spinal Cord to Enable Motor Function after Chronic Paralysis. J Neurotrauma. 2019 May 1;36(9):1451-1460. doi: 10.1089/neu.2018.5921. Epub 2018 Dec 15.
Results Reference
background
PubMed Identifier
33584209
Citation
Gill ML, Linde MB, Hale RF, Lopez C, Fautsch KJ, Calvert JS, Veith DD, Beck LA, Garlanger KL, Sayenko DG, Lavrov IA, Thoreson AR, Grahn PJ, Zhao KD. Alterations of Spinal Epidural Stimulation-Enabled Stepping by Descending Intentional Motor Commands and Proprioceptive Inputs in Humans With Spinal Cord Injury. Front Syst Neurosci. 2021 Jan 28;14:590231. doi: 10.3389/fnsys.2020.590231. eCollection 2020.
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Spinal Cord Injury Epidural Stimulation
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