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Epidural Stimulation in Chronic Spinal Cord Injury Patients

NCT05690074 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-03-16

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injuries

Interventions

DEVICE

Spectra Wave Writer™ Spinal Cord Stimulator System

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

Sponsors & Collaborators

  • University Hospital, Motol

    lead OTHER

Principal Investigators

  • Jiri Kriz, MD, PhD · UH Motol - spinal cord unit

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-12-01
Completion
2025-12-30
FDA Device
Yes

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05690074 on ClinicalTrials.gov