Treatment for Nervous System Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Nervous System Diseases+5 More
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare skin-surface transcutaneous stimulation with implanted epidural stimulation for improving lower extremity function in people with incomplete spinal cord injuries.

Eligible Conditions
  • Nervous System Diseases
  • Wounds
  • Axonotmesis
  • Spinal Cord Injuries
  • Central Nervous System Diseases
  • Spinal Cord Diseases

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: 8-11 months

8-11 months
Berg Balance Test
Electromyography recording of LE and trunk muscles
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
Kinetic and kinematic gait analysis using 3D camera system - angle
Kinetic and kinematic gait analysis using 3D camera system - velocity
Motor evoked potentials - Amplitude
Motor evoked potentials - Latency
Neurogenic Bladder Symptom Score
Neuromuscular Recovery Scale
Six-minute walk test
Somatosensory evoked potentials
Spinal Cord Injury - Functional Index (SCI-FI) questionnaire
Spinal Cord
Ten-minute walk test
Walking Index for Spinal Cord Injury II
Wartenberg Pendulum Test

Trial Safety

Trial Design

0 Treatment Group

6 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 8-11 months

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,586 Previous Clinical Trials
1,566,501 Total Patients Enrolled
2 Trials studying Nervous System Diseases
68 Patients Enrolled for Nervous System Diseases
U.S. National Science FoundationFED
28 Previous Clinical Trials
7,914 Total Patients Enrolled
Rajiv Saigal, MD, PhDPrincipal Investigator - University of Washington
Harborview Medical Center, University of Washington Medical Center
Tufts University School Of Medicine (Medical School)

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
They are in a stable medical condition and do not have cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in lower extremity rehabilitation or testing activities.
The study participants were willing and able to have the surgical implantation of the epidural stimulator for the treatment of pain according to the study timeline.
participants must be able to attend sessions that happen at least once a week and no more than once a month for 9 months.
means; This refers to people who are aged between 21 and 70.
have difficulty with leg functions and mobility in activities like walking, transferring surface to surface, and standing.
Some people with chronic pain are candidates for an implanted stimulator.
You have experienced chronic pain for at least 3 months.
they can be trained to respond to a cued motor task.
The participant will be able to attend 3-5 physical therapy sessions and testing activities per week for a period of three months.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 28th, 2021

Last Reviewed: November 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.