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Spinal Cord InjuryNCT02339233

Epi Stim to Facilitate Standing and Stepping

A study testing Standing and Stepping with spinal cord Epidural Stimulation in people with Spinal Cord Injury, run by University of Louisville 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

The overall aim is to assess whether task specific locomotor training and spinal cord electrical stimulation (SCES) can induce neural reorganization of the functionally isolated human spinal cord to improve standing and stepping in individuals with functionally complete SCI. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Spinal Cord Injury
What is being tested?
Standing and Stepping with spinal cord Epidural Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
1 Jan 2010to 3 Oct 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All research participants, irrespective of age or sex, will meet the following criteria:
  • stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate standing or stepping with BWST;
  • no painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training;
  • no clinically significant depression or ongoing drug abuse;
  • no current anti-spasticity medication regimen;
  • non-progressive SCI above T10;
Show all 15Show fewer
  • must not have received botox injections in the prior six months;
  • be unable to stand or step independently;
  • at least one-year post injury; and
  • must be at least 18 years of age.
  • In addition, all subjects must satisfy each of the three conditions of the functional neurophysiological assessment described below.
  • Functional Neurophysiological Assessment (FNPA). We will use FNPA to screen potential research participants based on specific neurophysiological inclusion criteria. Participants must have no volitional control of movement below the level of the lesion, but must retain some brain influence on spinal reflexes. Our target population, which will be identified by FNPA, cannot be identified reliable using traditional assessments: hence individual subjects may be classified widely as Class A, B, or C on the ASIA SCI scale. We will include only subjects who fulfill the following three requirements:
  • There is no descending volitional control of movement below the lesion
  • Segmental reflexes remain functional below the lesion
  • Brain influence on spinal reflexes is retained

Who cannot join

  • Ventilatory dependent
  • painful musculoskeletal function, unhealed fracture, contracture, or pressure sore that might interfere with training;
  • clinically significant depression or ongoing drug abuse;
  • cardiovascular, respiratory, bladder or renal disease unrelated to SCI;
  • severe anemia (Hgb<8 g/dL) or hypovolemia; and
  • HIV or AIDS related illness.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Louisville

    Louisville, Kentucky, 40202

Other trials in United States

About this study

Official title: Spinal Epidural Electrode Array to Facilitate Standing and Stepping After Spinal Cord Injury

The overall aim is to assess whether task specific locomotor training and spinal cord electrical stimulation (SCES) can induce neural reorganization of the functionally isolated human spinal cord to improve standing and stepping in individuals with functionally complete SCI. The investigators propose that locomotor training will result in generation of more effective standing and stepping efferent patterns by restoring phase dependent modulation of reflexes and reciprocal inhibition, reducing clonus and mediating interlimb coordination. The investigators propose that the SCES will optimize the physiological state of the spinal cord interneuronal circuitry compromised by compensating for loss of supraspinal input for the retraining of these tasks.

Read the detailed description

Participants will be screened for eligibility and then participate in pre-training motor, bladder and cardiovascular experiments, followed by 80 sessions of locomotor training. Participants will repeat experiments after the 80 training sessions to quantify that no motor pattern changes are achievable with locomotor training alone and will be evaluated for appropriate candidacy for surgery and epidural stimulation. Participants will be surgically implanted with an epidural stimulator and experiments will be conducted with and without stimulation. Investigators will identify appropriate stimulation parameters for inducing stepping and standing in combination with manual assistance using body weight support on a treadmill and/or overground. Participants will undergo 80-200 training sessions of locomotor training with epidural stimulation. Experiments will be repeated mid and post-training interventions.

Being tested
Standing and Stepping with spinal cord Epidural Stimulation
Keywords
Epidural Stimulation
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.

  • Standing and Stepping with spinal cord Epidural StimulationDevice

    Also called Stand-scES, Step-scES, Locomotor Training (LT)

    Standing and Stepping with support from trainers as needed, overground or in a harness with body weight support on a treadmill. Epidural stimulation with specific configurations will be administered to generate standing and stepping.

Study groups in NCT02339233
Study groupRoleWhat they receive
Epidural StimulatorExperimentalEligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord
Receives: Device: Standing and Stepping with spinal cord Epidural Stimulation

What is being measured

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

  1. Change From Baseline of Lower Extremity Independence Time During 10 Min Standing Bout After 160 Sessions (1 Year)

    We will measure the amount of time individuals are able to stand without manual assistance (independently) throughout a 10 min bout

    Measured: Baseline, 160 sessions (1 year)

  2. Change From Baseline of Stepping Independence Time During 6 Min Stepping Bout After 160 Sessions (1 Year)

    We will measure the number of steps individuals are able to take without manual assistance (independently) throughout a 6 min stepping bout

    Measured: Baseline, 160 session (1 year)

Secondary outcomes (1)

  1. Change From Baseline of Number of Consecutive Hip Flexion Repetitions Performed Within One Minute After 160 Sessions (1 Year)

    We will measure the ability of the individuals to perform consecutive hip flexion repetitions with stimulation during a 1 minute period

    Measured: Baseline, 160 sessions (1 year)

Timeline

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

  1. First posted15 Jan 2015 (estimated)
  2. Study start1 Jan 2010
  3. Primary completion3 Oct 2019
  4. Study completion3 Oct 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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02339233
Sponsor's protocol ID
07.0066 Epi Stim
Other IDs
5R01EB007615
Status last verified
Apr 2022
First submitted
12 Jan 2015
Last updated
22 Apr 2022
Data monitoring committee
Yes

Publications

  • Herrity AN, Williams CS, Angeli CA, Harkema SJ, Hubscher CH. Lumbosacral spinal cord epidural stimulation improves voiding function after human spinal cord injury. Sci Rep. 2018 Jun 6;8(1):8688. doi: 10.1038/s41598-018-26602-2.

    PubMed 29875362

  • Mesbah S, Angeli CA, Keynton RS, El-Baz A, Harkema SJ. A novel approach for automatic visualization and activation detection of evoked potentials induced by epidural spinal cord stimulation in individuals with spinal cord injury. PLoS One. 2017 Oct 11;12(10):e0185582. doi: 10.1371/journal.pone.0185582. eCollection 2017.

    PubMed 29020054

  • Sayenko DG, Angeli C, Harkema SJ, Edgerton VR, Gerasimenko YP. Neuromodulation of evoked muscle potentials induced by epidural spinal-cord stimulation in paralyzed individuals. J Neurophysiol. 2014 Mar;111(5):1088-99. doi: 10.1152/jn.00489.2013. Epub 2013 Dec 11.

    PubMed 24335213

  • Angeli CA, Edgerton VR, Gerasimenko YP, Harkema SJ. Altering spinal cord excitability enables voluntary movements after chronic complete paralysis in humans. Brain. 2014 May;137(Pt 5):1394-409. doi: 10.1093/brain/awu038. Epub 2014 Apr 8.

    PubMed 24713270

  • Angeli CA, Boakye M, Morton RA, Vogt J, Benton K, Chen Y, Ferreira CK, Harkema SJ. Recovery of Over-Ground Walking after Chronic Motor Complete Spinal Cord Injury. N Engl J Med. 2018 Sep 27;379(13):1244-1250. doi: 10.1056/NEJMoa1803588. Epub 2018 Sep 24.

    PubMed 30247091

  • Rejc E, Angeli CA, Atkinson D, Harkema SJ. Motor recovery after activity-based training with spinal cord epidural stimulation in a chronic motor complete paraplegic. Sci Rep. 2017 Oct 26;7(1):13476. doi: 10.1038/s41598-017-14003-w.

    PubMed 29074997

  • Rejc E, Angeli CA, Bryant N, Harkema SJ. Effects of Stand and Step Training with Epidural Stimulation on Motor Function for Standing in Chronic Complete Paraplegics. J Neurotrauma. 2017 May 1;34(9):1787-1802. doi: 10.1089/neu.2016.4516. Epub 2016 Oct 5.

    PubMed 27566051

  • Rejc E, Angeli C, Harkema S. Effects of Lumbosacral Spinal Cord Epidural Stimulation for Standing after Chronic Complete Paralysis in Humans. PLoS One. 2015 Jul 24;10(7):e0133998. doi: 10.1371/journal.pone.0133998. eCollection 2015.

    PubMed 26207623

  • Harkema S, Gerasimenko Y, Hodes J, Burdick J, Angeli C, Chen Y, Ferreira C, Willhite A, Rejc E, Grossman RG, Edgerton VR. Effect of epidural stimulation of the lumbosacral spinal cord on voluntary movement, standing, and assisted stepping after motor complete paraplegia: a case study. Lancet. 2011 Jun 4;377(9781):1938-47. doi: 10.1016/S0140-6736(11)60547-3. Epub 2011 May 19.

    PubMed 21601270

Questions about this trial

What is this clinical trial studying?

A study testing Standing and Stepping with spinal cord Epidural Stimulation in people with Spinal Cord Injury, run by University of Louisville 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 15 inclusion and 6 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 22 Apr 2022. 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?

Yes. Results are posted in the registry (first posted 22 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline of Lower Extremity Independence Time During 10 Min Standing Bout After 160 Sessions (1 Year) (time frame: Baseline, 160 sessions (1 year)). The study lists 2 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 NCT02339233, which also lists 9 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 22 Apr 2022.

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