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Procedure

Non-invasive Neuro-orthosis for Quadriplegia

N/A

Recruiting

Led By Lauren Wengerd, PhD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Sustained a chronic (>12 months) cervical SCI (AIS A, B, C, or D)

Age 22 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

Study Summary

This trial tests the safety & efficacy of a non-invasive device worn on the forearm (NeuroLife EMG-FES Sleeve) to help people with tetraplegia due to spinal cord injury. It measures outcomes over 12 weeks of intensive, task-oriented rehabilitation.

Who is the study for?

This trial is for adults over 22 with chronic tetraplegia from a spinal cord injury, who can't grasp objects but can move their shoulders and elbows. They must be able to attend sessions in person and give informed consent. It's not for those with pacemakers, uncontrolled seizures or conditions that could affect safety or results.Check my eligibility

What is being tested?

The NeuroLife EMG-FES Sleeve System is being tested on individuals with tetraplegia due to spinal cord injury. This non-invasive device uses electrodes to stimulate muscle activity in the forearm, aiming to restore hand function through rehabilitation therapy three times a week for twelve weeks.See study design

What are the potential side effects?

Potential side effects may include skin irritation from the electrodes, discomfort from electrical stimulation, muscle fatigue after use of the system, and possible exacerbation of spasticity or autonomic dysreflexia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a spinal cord injury in my neck area for over a year.

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I am 22 years old or older.

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I can attend all study sessions in person.

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I cannot grasp or handle objects to take care of my daily needs by myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 4-week post-intervention follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 4-week post-intervention follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4-week post-intervention follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Aim 1: Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) (Object Manipulation Subtest)

Aim 2: Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP), v2

Aim 3: Grasp and Release Test (GRT)

Secondary outcome measures

Aim 1: Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP), v2 (Prehension Performance Subtest)

Aim 2: Spinal Cord Independence Measure (SCIM)-III

Other outcome measures

Demographics/History

Expedited International Standards for Neurological Classification of SCI (E-ISNCSCI)

Tetraplegia Upper Limb Activities Questionnaire (TUAQ)

Trial Design

1Treatment groups

Experimental Treatment

Group I: NeuroLife EMG-FES Sleeve SystemExperimental Treatment1 Intervention

The NeuroLife EMG-FES System is a completely non-invasive system (surface electrodes only, no implantable components) worn on the forearm of participants and has up to 160 electrodes that can record electromyography (EMG), or muscle activity, and also electrically stimulate (FES) muscles. Using this combined, closed-loop technology participants will complete a 12-week protocol with a study therapist practicing functional activities using their hand/forearm while wearing the NeuroLife EMG-FES Sleeve System.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

830 Previous Clinical Trials

505,608 Total Patients Enrolled

United States Department of DefenseFED

865 Previous Clinical Trials

327,687 Total Patients Enrolled

Battelle Memorial InstituteOTHER

11 Previous Clinical Trials

1,741 Total Patients Enrolled

Frequently Asked Questions

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

Are there opportunities for individuals to join this research experiment?

"Affirmative. The clinical trial database shows that this research initiative, which was initially advertised on October 31st 2023, is still seeking participants. They need to recruit 12 people from two different sites."

Answered by AI

How many individuals are being administered therapy through this investigation?

"Affirmative. The clinical trial is actively recruiting, as indicated on the clinicaltrials.gov website. It was initially posted on October 31st 2023 and recently modified on October 12th of the same year. There are two sites seeking to recruit a total of twelve patients for this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia

Lauren Wengerd 2023. "A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06087445.