Back to resultsEpidural Stimulation in Chronic Spinal Cord Injury Patients
Primary Purpose
Spinal Cord Injuries
Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Spectra Wave Writer™ Spinal Cord Stimulator System
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injury, spinal cord stimulation, volitional movement, functional magnetic resonance imaging, autonomic nervous system
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.
Sites / Locations
- UH MotolRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with chronic spinal cord injury
Arm Description
80 sessions each of epidural spinal cord stimulation for 1) autonomic functions 2) voluntary movement; and 3) standing
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Change in trunk stability restoration
Trunk control stability test in individuals with spinal cord injury (SCI)
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.
Sexual function as measured by the Sexual Function Questionnaire
The Sexual Function Questionnaire (SFQ) is a self-report outcome measure of sexual function.
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.
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.
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.
Reduction of neuropathic pain
We will measure neuropathic pain by the Neuropathic Pain Questionnaire (NPQ)
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.
Full Information
NCT ID
NCT05690074
First Posted
December 2, 2022
Last Updated
March 13, 2023
Sponsor
University Hospital, Motol
1. Study Identification
Unique Protocol Identification Number
NCT05690074
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Motol
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
spinal cord injury, spinal cord stimulation, volitional movement, functional magnetic resonance imaging, autonomic nervous system
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with chronic spinal cord injury
Arm Type
Experimental
Arm Description
80 sessions each of epidural spinal cord stimulation for 1) autonomic functions 2) voluntary movement; and 3) standing
Intervention Type
Device
Intervention Name(s)
Spectra Wave Writer™ Spinal Cord Stimulator System
Intervention Description
Device: 5-6-5 Specify electrode Device: Restore Advance Pulse Generator
Primary Outcome Measure Information:
Title
Brain functional connectivity
Description
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.
Time Frame
1 year after implantation
Title
Change from baseline of lower extremity independence time during after 1 year of stimulation
Description
Researchers will measure the amount of time individuals are able to stand without manual assistance (independently).
Time Frame
1 year after stimulation (360 training sessions)
Secondary Outcome Measure Information:
Title
Change in trunk stability restoration
Description
Trunk control stability test in individuals with spinal cord injury (SCI)
Time Frame
6 month and 1 year after implantation
Title
Neurogenic bladder symptoms will be measured using the Neurogenic Bladder Symptom Score (NBSS).
Description
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.
Time Frame
3 month, 6 month, 9 month, 12 month
Title
Sexual function as measured by the Sexual Function Questionnaire
Description
The Sexual Function Questionnaire (SFQ) is a self-report outcome measure of sexual function.
Time Frame
3 month, 6 month, 9 month, 12 month
Title
Change in sense of wellbeing as measured by the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire
Description
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.
Time Frame
3 month, 6 month, 9 month, 12 month
Title
Symptoms of spasticity will be measured by Modified Ashworth spasticity test
Description
The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone.
Time Frame
3 month, 6 month, 9 month, 12 month
Title
Neurogenic bowel symptoms will be measured using the Neurogenic Bowel Dysfunction (NBD) score.
Description
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.
Time Frame
3 month, 6 month, 9 month, 12 month
Title
Reduction of neuropathic pain
Description
We will measure neuropathic pain by the Neuropathic Pain Questionnaire (NPQ)
Time Frame
3 month, 6 month, 9 month, 12 month
Title
Change in BP during the head up tilt test (HUTT)
Description
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.
Time Frame
6 month -1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vojtech Rybka, Dr.
Phone
+420224439253
Email
vojtech.rybka@fnmotol.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiri Kriz, MD, PhD
Organizational Affiliation
UH Motol - spinal cord unit
Official's Role
Study Chair
Facility Information:
Facility Name
UH Motol
City
Prague
ZIP/Postal Code
15000
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vojtech Rybka, Dr.
Phone
+420224439253
Email
vojtech.rybka@fnmotol.cz
12. IPD Sharing Statement
Citations:
PubMed Identifier
24713270
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. Erratum In: Brain. 2015 Feb;138(Pt 2):e330.
Results Reference
background
PubMed Identifier
21601270
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.
Results Reference
background
PubMed Identifier
26077679
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.
Results Reference
background
PubMed Identifier
30382197
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.
Results Reference
background
PubMed Identifier
34720867
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.
Results Reference
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PubMed Identifier
33907008
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.
Results Reference
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PubMed Identifier
32714156
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.
Results Reference
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Epidural Stimulation in Chronic Spinal Cord Injury Patients
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