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Spinal Cord InjuryNCT02592668

Spinal Cord Injury Epidural Stimulation

A study testing Epidural Stimulator in people with Spinal Cord Injury, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Spinal Cord Injury
What is being tested?
Epidural Stimulator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
4 Jan 2016to 11 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 22Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Feasibility Study: Epidural Stimulation to Enable Volitional Movement After Chronic Complete Paralysis in Humans.

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.

Being tested
Epidural Stimulator
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epidural StimulatorDevice

    Also called Medtronic Restore ULTRA 97712

    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.

Study groups in NCT02592668
Study groupRoleWhat they receive
Active stimulationExperimentalSubjects 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.
Receives: Device: Epidural Stimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of time for which subject can sit unassisted on the edge of a mat table

    Measured: Approximately 50 weeks after implantation

  2. Assessment of volitional movement of lower limbs

    Measured: Approximately 50 weeks after implantation

  3. Subject's ability to coordinate stepping on a treadmill will be measured using biomechanical and electrophysiological analyses

    Measured: Approximately 50 weeks after implantation

  4. Duration of time for which subject can stand weight bearing with minimal assistance provided as needed.

    Measured: Approximately 50 weeks after implantation

Secondary outcomes (12)

  1. Change in volitional movement restoration via NeuroRecovery scale

    Measured: baseline, approximately 50 weeks after implantation

  2. Change of bladder function, as measured by the Neurogenic Bladder Symptom Score questionnaire

    Measured: baseline, approximately 50 weeks after implantation

  3. Change in sexual function as measured by the Sexual Function Questionnaire

    Measured: baseline, approximately 50 weeks after implantation

  4. Change in body thermoregulatory capacity as measured by thermoregulatory sweat testing

    Measured: baseline, approximately 50 weeks after implantation

  5. Change in lean body mass

    Measured: baseline, approximately 50 weeks after implantation

  6. Change in bone density

    Measured: baseline, approximately 50 weeks after implantation

  7. Change in sense of wellbeing as measured by the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire

    Measured: baseline, approximately 50 weeks after implantation

  8. Change in sitting balance via functional reach test

    Measured: baseline, approximately 50 weeks after implantation

  9. Change in spasticity via Ashworth spasticity test

    Measured: baseline, approximately 50 weeks after implantation

  10. Change in ability of performing basic activities of daily life via spinal cord independence measure

    Measured: baseline, approximately 50 weeks after implantation

  11. Change in total body fat

    Measured: baseline, approximately 50 weeks after implantation

  12. Change in bowel function as measured by the Neurogenic Bowel Dysfunction Score questionnaire

    Measured: baseline, approximately 50 weeks after implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2015 (estimated)
  2. Study start4 Jan 2016
  3. Primary completion14 Sep 2018
  4. Study completion11 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02592668
Sponsor's protocol ID
15-000510
Other IDs
UL1TR000135
Status last verified
Apr 2020
First submitted
22 Oct 2015
Last updated
13 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 28385196

  • 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.

    PubMed 30250140

  • 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.

    PubMed 30430902

  • 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.

    PubMed 33584209

Questions about this trial

What is this clinical trial studying?

A study testing Epidural Stimulator in people with Spinal Cord Injury, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of time for which subject can sit unassisted on the edge of a mat table (time frame: Approximately 50 weeks after implantation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02592668, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.

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