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Spinal Cord InjuriesNCT05690074

Epidural Stimulation in Chronic Spinal Cord Injury Patients

A study testing Spectra Wave Writer™ Spinal Cord Stimulator System in people with Spinal Cord Injuries, run by University Hospital, Motol at 1 site in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Spectra Wave Writer™ Spinal Cord Stimulator System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteCzechia
Study dates
1 Jan 2023to 30 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Vojtech Rybka, Dr. contact

+420224439253

vojtech.rybka@fnmotol.cz

Czechia1 site, 1 recruiting

  • UH Motol

    Prague, 15000

    Vojtech Rybka, Dr., +420224439253, vojtech.rybka@fnmotol.cz

    Recruiting

Other trials in Czechia

About this study

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

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.

Being tested
Spectra Wave Writer™ Spinal Cord Stimulator System
Keywords
spinal cord injury, spinal cord stimulation, volitional movement, functional magnetic resonance imaging, autonomic nervous system
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spectra Wave Writer™ Spinal Cord Stimulator SystemDevice

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

Study groups in NCT05690074
Study groupRoleWhat they receive
Patients with chronic spinal cord injuryExperimental80 sessions each of epidural spinal cord stimulation for 1) autonomic functions 2) voluntary movement; and 3) standing
Receives: Device: Spectra Wave Writer™ Spinal Cord Stimulator System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year after implantation

  2. 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).

    Measured: 1 year after stimulation (360 training sessions)

Secondary outcomes (8)

  1. Change in trunk stability restoration

    Trunk control stability test in individuals with spinal cord injury (SCI)

    Measured: 6 month and 1 year after implantation

  2. 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.

    Measured: 3 month, 6 month, 9 month, 12 month

  3. Sexual function as measured by the Sexual Function Questionnaire

    The Sexual Function Questionnaire (SFQ) is a self-report outcome measure of sexual function.

    Measured: 3 month, 6 month, 9 month, 12 month

  4. 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.

    Measured: 3 month, 6 month, 9 month, 12 month

  5. 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.

    Measured: 3 month, 6 month, 9 month, 12 month

  6. 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.

    Measured: 3 month, 6 month, 9 month, 12 month

  7. Reduction of neuropathic pain

    We will measure neuropathic pain by the Neuropathic Pain Questionnaire (NPQ)

    Measured: 3 month, 6 month, 9 month, 12 month

  8. 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.

    Measured: 6 month -1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2023
  2. Study start1 Jan 2023
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05690074
Sponsor's protocol ID
EK-1302/21
Status last verified
Mar 2023
First submitted
2 Dec 2022
Last updated
16 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 24713270

  • 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.

    PubMed 21601270

  • 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.

    PubMed 26077679

  • 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.

    PubMed 30382197

  • 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.

    PubMed 34720867

  • 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.

    PubMed 33907008

  • 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.

    PubMed 32714156

Questions about this trial

What is this clinical trial studying?

A study testing Spectra Wave Writer™ Spinal Cord Stimulator System in people with Spinal Cord Injuries, run by University Hospital, Motol at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Vojtech Rybka, Dr. (+420224439253, vojtech.rybka@fnmotol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain functional connectivity (time frame: 1 year after implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05690074, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.

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