Clinical trial NCT05690074: Epidural Stimulation in Chronic Spinal Cord Injury Patients
Official title: Monitoring the Effect of Epidural Stimulation on Sensorimotor and Autonomic Functions in Chronic Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: spinal cord injury
spinal cord stimulation
volitional movement
functional magnetic resonance imaging
autonomic nervous system
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Brain functional connectivity
timeFrame: 1 year after implantation
measure: Change from baseline of lower extremity independence time during after 1 year of stimulation
timeFrame: 1 year after stimulation (360 training sessions)
Secondary outcomes:
measure: Change in trunk stability restoration
timeFrame: 6 month and 1 year after implantation
measure: Neurogenic bladder symptoms will be measured using the Neurogenic Bladder Symptom Score (NBSS).
timeFrame: 3 month, 6 month, 9 month, 12 month
measure: Sexual function as measured by the Sexual Function Questionnaire
timeFrame: 3 month, 6 month, 9 month, 12 month
measure: Change in sense of wellbeing as measured by the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire
timeFrame: 3 month, 6 month, 9 month, 12 month
measure: Symptoms of spasticity will be measured by Modified Ashworth spasticity test
timeFrame: 3 month, 6 month, 9 month, 12 month
measure: Neurogenic bowel symptoms will be measured using the Neurogenic Bowel Dysfunction (NBD) score.
timeFrame: 3 month, 6 month, 9 month, 12 month
measure: Reduction of neuropathic pain
timeFrame: 3 month, 6 month, 9 month, 12 month
measure: Change in BP during the head up tilt test (HUTT)
timeFrame: 6 month -1 year
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: UH Motol
Study officials:
affiliation: UH Motol - spinal cord unit
name: Jiri Kriz, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
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.
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.
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.
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.
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.
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.