Epidural Stimulation in Chronic Spinal Cord Injury Patients

March 13, 2023 updated by: Vojtech Rybka, MD, University Hospital, Motol

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with chronic spinal cord injury
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
Device: 5-6-5 Specify electrode Device: Restore Advance Pulse Generator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain functional connectivity
Time Frame: 1 year after implantation
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
Time Frame: 1 year after stimulation (360 training sessions)
Researchers will measure the amount of time individuals are able to stand without manual assistance (independently).
1 year after stimulation (360 training sessions)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in trunk stability restoration
Time Frame: 6 month and 1 year after implantation
Trunk control stability test in individuals with spinal cord injury (SCI)
6 month and 1 year after implantation
Neurogenic bladder symptoms will be measured using the Neurogenic Bladder Symptom Score (NBSS).
Time Frame: 3 month, 6 month, 9 month, 12 month
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.
3 month, 6 month, 9 month, 12 month
Sexual function as measured by the Sexual Function Questionnaire
Time Frame: 3 month, 6 month, 9 month, 12 month
The Sexual Function Questionnaire (SFQ) is a self-report outcome measure of sexual function.
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
Time Frame: 3 month, 6 month, 9 month, 12 month
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.
3 month, 6 month, 9 month, 12 month
Symptoms of spasticity will be measured by Modified Ashworth spasticity test
Time Frame: 3 month, 6 month, 9 month, 12 month
The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone.
3 month, 6 month, 9 month, 12 month
Neurogenic bowel symptoms will be measured using the Neurogenic Bowel Dysfunction (NBD) score.
Time Frame: 3 month, 6 month, 9 month, 12 month
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.
3 month, 6 month, 9 month, 12 month
Reduction of neuropathic pain
Time Frame: 3 month, 6 month, 9 month, 12 month
We will measure neuropathic pain by the Neuropathic Pain Questionnaire (NPQ)
3 month, 6 month, 9 month, 12 month
Change in BP during the head up tilt test (HUTT)
Time Frame: 6 month -1 year
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.
6 month -1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Motol

Investigators

  • Study Chair: Jiri Kriz, MD, PhD, UH Motol - spinal cord unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 30, 2025

Study Registration Dates

First Submitted

December 2, 2022

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-1302/21

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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