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

Sponsor

University Hospital, Motol (Other)

Overall Status

Recruiting

CT.gov ID

NCT05690074

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries	Device: Spectra Wave Writer™ Spinal Cord Stimulator System	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 30, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 30, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Change in trunk stability restoration [6 month and 1 year after implantation]
Trunk control stability test in individuals with spinal cord injury (SCI)
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.
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.
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.
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.
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)
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.