Epidural Stimulation in Chronic Spinal Cord Injury Patients

Spinal Cord Injuries Clinical Trial

Official title:

Monitoring the Effect of Epidural Stimulation on Sensorimotor and Autonomic Functions in Chronic Patients With Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05690074
• Other study ID #: EK-1302/21
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2023
• Source: University Hospital, Motol
• Contact: Vojtech Rybka, Dr.
• Phone: +420224439253
• Email: vojtech.rybka[@]fnmotol.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators propose to demonstrate that epidural stimulation (ES) can be used to recover significant levels of autonomic control of cardiovascular, urinary and sexual function as well as the ability to voluntarily control leg movements below the injury level. This intervention would provide an immediate therapeutic alternative to individuals who now have no recourse for treatment. In addition investigators suggest to prove on functional magnetic resonance imaging if there are some significant changes before and after the stimulation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 30, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• non-progressive SCI with complete motor paralysis below T1; American Spinal Injury Association Impairment Scale (AIS) A or B
• 18 - 60 years of age;
• longer than 2 years post injury;
• stable medical condition
• unable to voluntarily move all single joints of the legs;
• spinal cort lesion between C7 and Th10

Exclusion Criteria:

• ventilator dependent;
• painful musculoskeletal dysfunction, 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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• Spectra Wave Writer™ Spinal Cord Stimulator System
Device: 5-6-5 Specify electrode Device: Restore Advance Pulse Generator

Locations

Country	Name	City	State
Czechia	UH Motol	Prague

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Motol

Country where clinical trial is conducted

Czechia, 

References & Publications (7)

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. Erratum In: Brain. 2015 Feb;138(Pt 2):e330. — View Citation

Choi EH, Gattas S, Brown NJ, Hong JD, Limbo JN, Chan AY, Oh MY. Epidural electrical stimulation for spinal cord injury. Neural Regen Res. 2021 Dec;16(12):2367-2375. doi: 10.4103/1673-5374.313017. — View Citation

Gerasimenko YP, Lu DC, Modaber M, Zdunowski S, Gad P, Sayenko DG, Morikawa E, Haakana P, Ferguson AR, Roy RR, Edgerton VR. Noninvasive Reactivation of Motor Descending Control after Paralysis. J Neurotrauma. 2015 Dec 15;32(24):1968-80. doi: 10.1089/neu.2015.4008. Epub 2015 Aug 20. — View Citation

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. — View Citation

Pena Pino I, Hoover C, Venkatesh S, Ahmadi A, Sturtevant D, Patrick N, Freeman D, Parr A, Samadani U, Balser D, Krassioukov A, Phillips A, Netoff TI, Darrow D. Long-Term Spinal Cord Stimulation After Chronic Complete Spinal Cord Injury Enables Volitional Movement in the Absence of Stimulation. Front Syst Neurosci. 2020 Jun 30;14:35. doi: 10.3389/fnsys.2020.00035. eCollection 2020. — View Citation

Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31. — View Citation

Zhang H, Liu Y, Zhou K, Wei W, Liu Y. Restoring Sensorimotor Function Through Neuromodulation After Spinal Cord Injury: Progress and Remaining Challenges. Front Neurosci. 2021 Oct 14;15:749465. doi: 10.3389/fnins.2021.749465. eCollection 2021. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain functional connectivity	Researchers want to describe if there are some changes on functional MRI of the spinal cord and brain before and after stimulation. With functional MRI in rest and task condition, the functional connectivity (FC) is examined.	1 year after implantation
Primary	Change from baseline of lower extremity independence time during after 1 year of stimulation	Researchers will measure the amount of time individuals are able to stand without manual assistance (independently).	1 year after stimulation (360 training sessions)
Secondary	Change in trunk stability restoration	Trunk control stability test in individuals with spinal cord injury (SCI)	6 month and 1 year after implantation
Secondary	Neurogenic bladder symptoms will be measured using the Neurogenic Bladder Symptom Score (NBSS).	Assessment of neurogenic bladder symptoms will be performed to assess the impact of long term eSCS on this measure. The score measures bladder symptoms across 3 different domains: incontinence (scored 0-29), storage and voiding (scored 0-22), and consequences (scored 0-23), with higher scores representing worse symptoms.	3 month, 6 month, 9 month, 12 month
Secondary	Sexual function as measured by the Sexual Function Questionnaire	The Sexual Function Questionnaire (SFQ) is a self-report outcome measure of sexual function.	3 month, 6 month, 9 month, 12 month
Secondary	Change in sense of wellbeing as measured by the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire	The WHOQOL-BREF assesses quality of life (QOL) within the context of an individual's culture, value systems, personal goals, standards and concerns. The higher score in the questionnaire means better quality of life for patient.	3 month, 6 month, 9 month, 12 month
Secondary	Symptoms of spasticity will be measured by Modified Ashworth spasticity test	The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone.	3 month, 6 month, 9 month, 12 month
Secondary	Neurogenic bowel symptoms will be measured using the Neurogenic Bowel Dysfunction (NBD) score.	Assessment of neurogenic bowel symptoms will be performed to assess the impact of long term eSCS on this measure. Scores can range from 0-47, with a higher score representing more severe dysfunction.	3 month, 6 month, 9 month, 12 month
Secondary	Reduction of neuropathic pain	We will measure neuropathic pain by the Neuropathic Pain Questionnaire (NPQ)	3 month, 6 month, 9 month, 12 month
Secondary	Change in BP during the head up tilt test (HUTT)	During HUTT, participants will be passively moved to approximately 60° upright stand position by the investigators using the tilt table. Using epidural spinal cord stimulation (eSCS) to activate spinal sympathetic circuitry and mitigate low resting BP and orthostatic hypotension (OH) and continuous beat-by beat BP monitoring via finger photoplethysmography.	6 month -1 year