Epidural Stimulation in Chronic Spinal Cord Injury Patients

NCT ID: NCT05690074

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-12-30

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with chronic spinal cord injury

80 sessions each of epidural spinal cord stimulation for 1) autonomic functions 2) voluntary movement; and 3) standing

Group Type: EXPERIMENTAL

Spectra Wave Writer™ Spinal Cord Stimulator System

Intervention Type: DEVICE

Device: 5-6-5 Specify electrode Device: Restore Advance Pulse Generator

Interventions

Spectra Wave Writer™ Spinal Cord Stimulator System

Device: 5-6-5 Specify electrode Device: Restore Advance Pulse Generator

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Motol

OTHER

Sponsor Role: lead

Responsible Party

Vojtech Rybka, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiri Kriz, MD, PhD

Role: STUDY_CHAIR

UH Motol - spinal cord unit

Locations

UH Motol

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Vojtech Rybka, Dr.

Role: CONTACT

vojtech.rybka@fnmotol.cz

+420224439253

Facility Contacts

Vojtech Rybka, Dr.

Role: primary

vojtech.rybka@fnmotol.cz

+420224439253

References

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.

Reference Type: BACKGROUND

PMID: 24713270 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21601270 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26077679 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30382197 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34720867 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33907008 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32714156 (View on PubMed)

Other Identifiers

EK-1302/21

Identifier Type: -

Identifier Source: org_study_id