Epidural Stimulation in Chronic Spinal Cord Injury Patients

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries
• Interventions: Device: Spectra Wave Writer™ Spinal Cord Stimulator System

• Registration Number: NCT05690074
• Lead Sponsor: University Hospital, Motol

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-02
• Study Start: 2023-01-01
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-19
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-16
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with chronic spinal cord injury	Spectra Wave Writer™ Spinal Cord Stimulator System	80 sessions each of epidural spinal cord stimulation for 1) autonomic functions 2) voluntary movement; and 3) standing

Primary Outcome Measures

Name	Time	Method
Brain functional connectivity	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.
Change from baseline of lower extremity independence time during after 1 year of stimulation	1 year after stimulation (360 training sessions)	Researchers will measure the amount of time individuals are able to stand without manual assistance (independently).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UH Motol; 🇨🇿 Prague, Czechia