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NCT02339233

Epi Stim to Facilitate Standing and Stepping

Completed NA Results posted Last updated 22 April 2022
What this trial tests

NA trial testing Standing and Stepping with spinal cord Epidural Stimulation in Spinal Cord Injury in 8 participants. Completed in 3 October 2019.

Timeline
1 January 2010
Primary endpoint
3 October 2019
3 October 2019

Quick facts

Lead sponsorUniversity of Louisville
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment8
Start date1 January 2010
Primary completion3 October 2019
Estimated completion3 October 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Louisville

Who can join

Adults 18 to 75, any sex, with Spinal Cord Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

GroupValue95% CI
Epidural Stimulator40.6± 30.2
Change From Baseline of Stepping Independence Time During 6 Min Stepping Bout After 160 Sessions (1 Year) Primary · Baseline, 160 session (1 year)

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

GroupValue95% CI
Epidural Stimulator197.13± 421.89
Change From Baseline of Number of Consecutive Hip Flexion Repetitions Performed Within One Minute After 160 Sessions (1 Year) Secondary · Baseline, 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

GroupValue95% CI
Epidural Stimulator14.25± 9.8

Adverse events — posted to ClinicalTrials.gov

Time frame: From implant through the end of the second intervention, an average of one year.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Epidural Stimulator
Serious: 2/8 (25%)
Deaths: 0/8

Serious adverse events (2 terms)

ReactionSystemEpidural Stimulator
Device MalfunctionSurgical and medical procedures
Hip FractureMusculoskeletal and connective tissue disorders
Other adverse events (5 terms — click to expand)

ReactionSystemEpidural Stimulator
Muscle StrainMusculoskeletal and connective tissue disorders
Flipped StimulatorSurgical and medical procedures
Electrode MalfunctionSurgical and medical procedures
Incision Site DrainageSkin and subcutaneous tissue disorders
Right Ankle EdemaMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Device Malfunction, Hip Fracture.

Data from ClinicalTrials.gov NCT02339233 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Recovery of Over-Ground Walking after Chronic Motor Complete Spinal Cord Injury.
    Angeli CA, Boakye M, Morton RA, Vogt J, et al · · 2018 · cited 470× · PMID 30247091 · DOI 10.1056/nejmoa1803588
  2. Recent advances in managing a spinal cord injury secondary to trauma.
    Ahuja CS, Martin AR, Fehlings M. · · 2016 · cited 94× · PMID 27303644 · DOI 10.12688/f1000research.7586.1
  3. Clinical Trials in Traumatic Spinal Cord Injury.
    Donovan J, Kirshblum S. · · 2018 · cited 68× · PMID 29736858 · DOI 10.1007/s13311-018-0632-5
  4. Delving into the recent advancements of spinal cord injury treatment: a review of recent progress.
    Flack JA, Sharma KD, Xie JY. · · 2022 · cited 52× · PMID 34269189 · DOI 10.4103/1673-5374.317961
  5. Improvements in Bladder Function Following Activity-Based Recovery Training With Epidural Stimulation After Chronic Spinal Cord Injury.
    Herrity AN, Aslan SC, Ugiliweneza B, Mohamed AZ, et al · · 2020 · cited 31× · PMID 33469421 · DOI 10.3389/fnsys.2020.614691
  6. Motor improvements enabled by spinal cord stimulation combined with physical training after spinal cord injury: review of experimental evidence in animals and humans.
    Seáñez I, Capogrosso M. · · 2021 · cited 29× · PMID 34706778 · DOI 10.1186/s42234-021-00077-5
  7. Spinal Cord Imaging Markers and Recovery of Volitional Leg Movement With Spinal Cord Epidural Stimulation in Individuals With Clinically Motor Complete Spinal Cord Injury.
    Rejc E, Smith AC, Weber KA, Ugiliweneza B, et al · · 2020 · cited 27× · PMID 33192348 · DOI 10.3389/fnsys.2020.559313
  8. Neurophysiological markers predicting recovery of standing in humans with chronic motor complete spinal cord injury.
    Mesbah S, Gonnelli F, Angeli CA, El-Baz A, et al · · 2019 · cited 22× · PMID 31597924 · DOI 10.1038/s41598-019-50938-y

Verify or expand the search:

Other recruiting trials for Spinal Cord Injury

Currently open trials in the same condition.

Other University of Louisville trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02339233.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing