Epi Stim to Facilitate Standing and Stepping

NCT02339233 | Completed Results DMC

• 2 other identifiers: 07.0066 Epi Stim5R01EB007615
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spinal Cord Injury

Keywords

Epidural Stimulation

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline, 160 sessions (1 year)

• 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

  Baseline, 160 session (1 year)

Secondary Outcomes (1)

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

  Baseline, 160 sessions (1 year)

Study Arms (1)

Epidural Stimulator

EXPERIMENTAL

Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord

Device: Standing and Stepping with spinal cord Epidural Stimulation

Interventions

Standing and Stepping with spinal cord Epidural Stimulation DEVICE

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.

Also known as: Stand-scES, Step-scES, Locomotor Training (LT)

Epidural Stimulator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead
• University of California, Los Angeles: collaborator
• Christopher Reeve Paralysis Foundation: collaborator
• Kessler Foundation: collaborator
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Publications (9)

• 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.

  PMID: 29875362 BACKGROUND

• 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.

  PMID: 29020054 BACKGROUND

• 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.

  PMID: 24335213 BACKGROUND

• 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.

  PMID: 24713270 RESULT

• 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.

  PMID: 30247091 RESULT

• 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.

  PMID: 29074997 RESULT

• 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.

  PMID: 27566051 RESULT

• 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.

  PMID: 26207623 RESULT

• 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.

  PMID: 21601270 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Dr. Susan Harkema
• Organization: University of Lousiville

susan.harkema@louisville.edu

502-581-8675

Study Officials

• Susan Harkema, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 15, 2015
• Study Start: January 1, 2010
• Primary Completion: October 3, 2019
• Study Completion: October 3, 2019
• Last Updated: April 22, 2022
• Results First Posted: April 22, 2022

Record last verified: 2022-04

Locations

US (1)