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User-controlled FES system for Spinal Cord Injury

N/A
Recruiting
Led By David A Friedenberg, PhD
Research Sponsored by Battelle Memorial Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 18 years old
≥ 12 months post-spinal cord injury (SCI) and medically/neurologically stable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights

Study Summary

This trial is testing a new, personalized, portable, and non-invasive hand-grasp neuro-orthosis that could help restore naturalistic grasp functions for people with tetraplegia due to spinal cord injury.

Who is the study for?
This trial is for adults over 18 with stable spinal cord injury causing tetraplegia, unable to grasp objects. They must have certain levels of arm and wrist muscle function and be able to attend sessions at home or a site. Excluded are those on ventilators, with specific medical devices, severe spasticity, recent Botox treatments in the arms, or other significant health risks.Check my eligibility
What is being tested?
The study tests a user-controlled FES system designed to restore hand-grasp functions in individuals with tetraplegia from spinal cord injuries. It aims to create personalized neuro-orthoses based on participants' needs and preferences.See study design
What are the potential side effects?
Potential side effects may include discomfort at the electrode sites, skin irritation under the sleeve of the device, muscle fatigue due to electrical stimulation, and possible exacerbation of existing conditions like spasticity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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It's been over a year since my spinal cord injury and my condition is stable.
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I can bend my elbow and extend my wrist with some strength.
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I have a spinal cord injury in my neck area not caused by a condition that worsens over time.
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I cannot independently grasp objects with both hands.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of FES sleeve as a functional orthosis for activities of daily living
Secondary outcome measures
Change in Electromyography (EMG) signal metrics
Change in Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) after 10 weeks
Number of serious adverse events
+2 more
Other outcome measures
Canadian Occupational Performance Measure (COPM)
Setup time (minutes)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Non-invasive FESExperimental Treatment1 Intervention
Wearable FES sleeve with non-invasive user controls

Find a Location

Who is running the clinical trial?

Battelle Memorial InstituteLead Sponsor
11 Previous Clinical Trials
1,745 Total Patients Enrolled
Ohio State UniversityOTHER
827 Previous Clinical Trials
502,743 Total Patients Enrolled
David A Friedenberg, PhDPrincipal InvestigatorBattelle

Frequently Asked Questions

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

Are there any remaining vacancies for trial participants?

"The details on clinicaltrials.gov point towards this trial actively searching for participants, with the original post date being April 5th 2022 and the most recent update occuring one day later."

Answered by AI

How many participants have been recruited for this research project?

"Affirmative. As per the information hosted by clinicaltrials.gov, this medical trial is actively recruiting volunteers. It was first made available on April 5th 2022 and has been recently updated as of April 6th 2022. There are 8 spots open at one location for potential participants to join in the study."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
Battelle Memorial Institute
What portion of applicants met pre-screening criteria?
Met criteria
~1 spots leftby Jul 2024