NCT05690074

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

2.9 years

First QC Date

December 2, 2022

Last Update Submit

March 13, 2023

Conditions

Spinal Cord Injuries

Keywords

spinal cord injuryspinal cord stimulationvolitional movementfunctional magnetic resonance imagingautonomic nervous system

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (8)

  • Change in trunk stability restoration

    6 month and 1 year after implantation

  • Neurogenic bladder symptoms will be measured using the Neurogenic Bladder Symptom Score (NBSS).

    3 month, 6 month, 9 month, 12 month

  • Sexual function as measured by the Sexual Function Questionnaire

    3 month, 6 month, 9 month, 12 month

  • Change in sense of wellbeing as measured by the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire

    3 month, 6 month, 9 month, 12 month

  • Symptoms of spasticity will be measured by Modified Ashworth spasticity test

    3 month, 6 month, 9 month, 12 month

  • +3 more secondary outcomes

Study Arms (1)

Patients with chronic spinal cord injury

EXPERIMENTAL

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

Device: Spectra Wave Writer™ Spinal Cord Stimulator System

Interventions

Spectra Wave Writer™ Spinal Cord Stimulator SystemDEVICE

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

Patients with chronic spinal cord injury

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • non-progressive SCI with complete motor paralysis below T1; American Spinal Injury Association Impairment Scale (AIS) A or B
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Motol

Prague, 15000, Czechia

RECRUITING

Related 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.

    PMID: 24713270BACKGROUND

  • 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: 21601270BACKGROUND

  • 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.

    PMID: 26077679BACKGROUND

  • 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.

    PMID: 30382197BACKGROUND

  • 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.

    PMID: 34720867BACKGROUND

  • 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.

    PMID: 33907008BACKGROUND

  • 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.

    PMID: 32714156BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Jiri Kriz, MD, PhD

    UH Motol - spinal cord unit

    STUDY CHAIR

Central Study Contacts

Vojtech Rybka, Dr.

CONTACT

+420224439253vojtech.rybka@fnmotol.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 2, 2022

First Posted

January 19, 2023

Study Start

January 1, 2023

Primary Completion

December 1, 2025

Study Completion

December 30, 2025

Last Updated

March 16, 2023

Record last verified: 2023-03

Locations

CZ(1)