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Spinal Cord Stimulation

Spinal Cord Stimulation for Spinal Cord Injury

N/A
Recruiting
Led By Chet Moritz, Ph.D.
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has difficulty with hand functions in activities of daily living (e.g., dressing, grooming, feeding)
Stable medical condition without cardiopulmonary disease or autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up "repeated measurements once every two weeks throughout the study, an average of 10 months".
Awards & highlights

Study Summary

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

Who is the study for?
This trial is for adults with a stable medical condition who have had a cervical spinal cord injury at least one year ago, can perform simple motor tasks, and attend sessions three times weekly. They must not be ventilator-dependent or have certain implants, drug abuse history, pregnancy, severe allergies, or other conditions that could interfere with the study.Check my eligibility
What is being tested?
The study tests non-invasive closed-loop electrical stimulation versus open-loop stimulation to improve hand function and reduce spasticity after spinal cord injuries. Participants will also engage in functional task practice as part of their therapy regimen.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from the electrical stimulation or skin irritation where electrodes are placed. There might also be risks associated with increased physical activity during rehabilitation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I struggle with daily tasks like dressing or feeding due to hand issues.
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My heart and lung health allows me to do arm exercises.
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I can perform simple tasks when guided.
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I have a spinal cord injury above my shoulders and still have some movement or sensation below the injury.
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I can attend training and assessment sessions 3 times a week.
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I have enough support to attend all required sessions for 40 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~"repeated measurements once every two weeks throughout the study, an average of 10 months".
This trial's timeline: 3 weeks for screening, Varies for treatment, and "repeated measurements once every two weeks throughout the study, an average of 10 months". for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
+1 more
Secondary outcome measures
Change from baseline Spinal Cord Independence Measure Self Report
Change from baseline- H-Reflex
Change from baseline- International Standards for Neurologic Classification of Spinal Cord Injury - Motor Score
+4 more
Other outcome measures
Change from baseline- International Spinal Cord Injury Bowel Function Basic Data Set.v.2.1
Change from baseline- Patient Reported Impact of Spasticity Measure
Change from baseline- Spinal Cord Injury - Functional Index Short-Form
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Open-loop StimulationExperimental Treatment2 Interventions
Continuous stimulation
Group II: Close-loop StimulationExperimental Treatment2 Interventions
Intended movement-based stimulation.

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,342 Total Patients Enrolled
Chet Moritz, Ph.D.Principal InvestigatorUniversity of Washington

Media Library

Closed-loop Stimulation (Spinal Cord Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05267951 — N/A
Spinal Cord Injury Research Study Groups: Open-loop Stimulation, Close-loop Stimulation
Spinal Cord Injury Clinical Trial 2023: Closed-loop Stimulation Highlights & Side Effects. Trial Name: NCT05267951 — N/A
Closed-loop Stimulation (Spinal Cord Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05267951 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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](https://www.withpower.com/clinical-trials/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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI
~1 spots leftby Aug 2024