Open-loop Stimulation for Spinal Cord Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Washington, Seattle, WASpinal Cord InjuryOpen-loop Stimulation - Device
Eligibility
21 - 70
All Sexes
What conditions do you have?
Select

Study Summary

This trialtests a non-invasive spinal cord stimulator to improve arm use & reduce stiffness in people with spinal cord injuries.

Eligible Conditions
  • Spinal Cord Injury

Treatment Effectiveness

Study Objectives

4 Primary · 7 Secondary · Reporting Duration: "Repeated measurements once every two weeks throughout the study, an average of 10 months".

"Baseline"/"At the end of each treatment arm"/"Through study completion"
Change from baseline- Spinal Cord Injury - Functional Index Short-Form
Month 10
Change from baseline Spinal Cord Independence Measure Self Report
Change from baseline- H-Reflex
Change from baseline- International Spinal Cord Injury Bowel Function Basic Data Set.v.2.1
Change from baseline- International Standards for Neurologic Classification of Spinal Cord Injury - Motor Score
Change from baseline- International Standards for Neurologic Classification of Spinal Cord Injury - Sensory Score
Change from baseline- International Standards of Autonomic Functions after Spinal Cord Injury
Change from baseline- Motor Evoked Potentials
Change from baseline- Patient Reported Impact of Spasticity Measure
Change from baseline- Somatosensory Evoked Potentials
Change from baseline- World Health Organization Quality of Life Questionnaire
Month 10
Change from baseline- Capabilities of Upper Extremity Test
Change from baseline- Graded Redefined Assessment of Strength, Sensation, and Prehension version 2
Change from baseline- Grip and Pinch Force
Change from baseline- Modified Ashworth Scale

Trial Safety

Trial Design

2 Treatment Groups

Open-loop Stimulation
1 of 2
Close-loop Stimulation
1 of 2

Experimental Treatment

9 Total Participants · 2 Treatment Groups

Primary Treatment: Open-loop Stimulation · No Placebo Group · N/A

Open-loop StimulationExperimental Group · 2 Interventions: Open-loop Stimulation, Functional Task Practice · Intervention Types: Device, Other
Close-loop StimulationExperimental Group · 2 Interventions: Close-loop Stimulation, Functional Task Practice · Intervention Types: Device, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: "repeated measurements once every two weeks throughout the study, an average of 10 months".

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,612 Previous Clinical Trials
1,573,594 Total Patients Enrolled
Chet Moritz, Ph.D.Principal InvestigatorUniversity of Washington

Eligibility Criteria

Age 21 - 70 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can perform simple physical movements with guidance.
You have trouble using your hands for everyday tasks like getting dressed or eating.
You have experienced a spinal cord injury in the upper part of your neck and it has been at least one year since the injury.

Frequently Asked Questions

What specific objectives are researchers attempting to attain with this clinical trial?

"The principal benchmark that needs to be observed over the course of 10 months is Change from baseline- Graded Redefined Assessment of Strength, Sensation, and Prehension version 2. Other secondary objectives comprise Change from baseline- International Standards of Autonomic Functions after Spinal Cord Injury (Clinician assessment), Change from baseline- International Standards for Neurologic Classification of Spinal Cord Injury - Motor Score (Standard manual muscle strength examination) and Change from baseline- Somatosensory Evoked Potentials (Electrophysiologic evaluation). The evaluations will take place biweekly throughout the trial period." - Anonymous Online Contributor

Unverified Answer

To what extent is this examination engaging people?

"Affirmative. Clinicaltrials.gov contains information that this experiment is actively recruiting participants and began recruitment on October 12th 2022, with the latest update being recorded a day later. The study requires 9 people from 1 facility to participate." - Anonymous Online Contributor

Unverified Answer

Does this trial continue to recruit participants?

"Affirmative. On clinicaltrials.gov, it is denoted that this medical trial was initially posted on December 10th 2022 and most recently updated on the 13th of that same month. Nine patients are required to be recruited at one centre for the study's completion." - Anonymous Online Contributor

Unverified Answer

Am I eligible to join the trial for this research project?

"This clinical trial requires the participation of 9 individuals between 21 and 70 years old who have suffered from a traumatic spinal cord injury. Additionally, these participants must possess C8 or higher cervical injuries (as classified by American Spinal Cord Injury Impairment Scale - C or D) that occurred at least one year ago; be able to complete simple motor tasks; read and speak English fluently; possess adequate social support for 40 weeks worth of sessions 3 times per week; not suffer from any cardiopulmonary disease nor autonomic dysreflexia which could limit their ability to actively participate in upper extremity rehabilitation activities or tests related to activities" - Anonymous Online Contributor

Unverified Answer

Is this experiment open to participants of a more advanced age?

"This trial requires participants to be at least 21 years old and no more than 70." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.