Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: implanted epidural stimulator.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury: Spared Fibers Proof-of-concept Study
Overview
This proof-of-concept case series will prospectively use magnetic resonance imaging (MRI) evidence of spared spinal cord neural fibers to guide the selection of 2 research participants to receive a surgically implanted epidural stimulator with the goal of restoring voluntary movement after spinal cord injury (SCI). Because MRI evidence of spared spinal cord neural fibers demonstrated significant relationships with responsiveness to epidural stimulation in SCI in retrospective studies, the proposed study is a traditional feasibility study - a prospective investigation to be used to capture preliminary safety and effectiveness information to determine if MRI can/should be used in planning a future pivotal study.
Detailed description
This is an investigator-initiated proof of concept study performed at the University of Colorado Anschutz Medical Campus (CU Anschutz).
This 2-case proof-of-concept study will include 2 research participants with motor-complete SCI to evaluate the performance of the Medtronic epidural stimulator for restoring voluntary movement below the level of injury.
Participants will be enrolled at CU Anschutz. Screening data will be reviewed to determine participant eligibility. Two participants who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
The following treatment regimen will be used: epidural stimulation + 6 months of intensive outpatient physical therapy.
Total duration of study participation will be 8 months.
Interventions
- Device implanted epidural stimulator
implantable multi-programmable neurostimulation system to deliver electrical stimulation to neural targets in the spinal cord
Primary outcome measures
- International Standards for Neurological Classification of Spinal Cord Injury lower extremity motor scores (ISNCSCI-LEMS) [Time frame: at day 1, at month 7, and at month 8]
Secondary outcome measures (1)
- The abbreviated World Health Organization Quality of Life (WHOQOL-BREF) [Time frame: at day 1, at month 7, and at month 8]
Eligibility criteria
Inclusion criteria
- American Spinal Injury Association Impairment Scale B spinal cord injury diagnosis
- Beyond 6 months of injury date
- Spinal cord injury at a level range of cervical 7 to thoracic 8 (C7-T8) with signs of upper motor neuron injury
- 18 years or older
- Height 5'1" to 6'3"
- Weight 250 lbs or less
- Sufficient upper extremity strength to manage a stability aide
- Magnetic resonance imaging evidence of spared spinal cord neural fibers
Exclusion criteria
- Claustrophobia and/or other contraindications to magnetic resonance imaging
- Unstable or symptomatic cardiorespiratory issues, in the opinion of the investigators
- Recent (within 3 months) history of fracture, contractures, pressure sore, deep vein thrombosis, urinary tract infection, or other infections that might interfere with interventions
- Contraindications to epidural stimulator implantation surgery
- Received botox injections into the lower extremities within the past 6 months
- Pregnancy
- Cauda Equina injury
- Any other neurological disorder besides spinal cord injury
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Colorado Anschutz — Aurora
Publications
- Smith AC, Angeli CA, Ugiliweneza B, Weber KA 2nd, Bert RJ, Negahdar M, Mesbah S, Boakye M, Harkema SJ, Rejc E. Spinal cord imaging markers and recovery of standing with epidural stimulation in individuals with clinically motor complete spinal cord injury. Exp Brain Res. 2022 Jan;240(1):279-288. doi: 10.1007/s00221-021-06272-9. Epub 2021 Dec 2. PMID 34854934
- Rejc E, Smith AC, Weber KA 2nd, Ugiliweneza B, Bert RJ, Negahdar M, Boakye M, Harkema SJ, Angeli CA. Spinal Cord Imaging Markers and Recovery of Volitional Leg Movement With Spinal Cord Epidural Stimulation in Individuals With Clinically Motor Complete Spinal Cord Injury. Front Syst Neurosci. 2020 Oct 21;14:559313. doi: 10.3389/fnsys.2020.559313. eCollection 2020. PMID 33192348
- 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
- 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
- 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
Identifiers
NCT: NCT05966896 · 23-0202 · 1K01HD106928-01A1