A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia
A legfontosabb adatok
- Ki végzi
- Ohio State University
- Hol
- Columbus (Egyesült Államok)Mind a 2 helyszín megnézése
- Azonosító
- Állapot
- Befejeződött
- Résztvevők
- 12 fő vett részt
- Kezdés
- 2023. okt. 31.
- Befejezés
- 2026. máj. 11.
- A vizsgálat típusa
- Beavatkozással járó
- A vizsgált kezelések
- NeuroLife EMG-FES Sleeve System
- A regiszteradat frissítve
- 2026. május 26.
Ki vehet részt
- Életkor
- 22 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 13 feltétel megnézéseKevesebb
Ki vehet részt
- age 22 years or older
- sustained a chronic (>12 months) cervical SCI (AIS A, B, C, or D) and is currently medically stable
- unable to grasp and manipulate objects to allow independent performance of activities of daily living (e.g., Tetraplegia)
- retain voluntary ability to enact unilateral shoulder and elbow movements either independently or with a mobile arm support
- Willing and able to attend study sessions in Columbus, Ohio for 12 weeks, 3x/week and all assessment sessions (4 weeks prior to and 4 weeks following 12-week intervention protocol)
- able to provide informed consent
Ki nem vehet részt
- medical contraindications to FES (e.g., pacemaker or other implanted devices, uncontrolled seizure disorder, cancer or open wounds on hands)
- comorbid medical condition that, in the opinion of the PI, that may impact participant safety or study results
- severe, uncontrolled autonomic dysreflexia
- severe upper extremity spasticity or contractures that prevent FES-evoked wrist and finger movements
- ventilator dependent
- pregnant or plan to become pregnant (females only)
- actively participating in upper extremity rehabilitation
Helyszínek itt: Egyesült Államok
- Battelle Memorial InstituteColumbus, Egyesült ÁllamokNo longer taking part
- Ohio State University Wexner Medical Center (Columbus Campus, Dodd Hall, Martha Morehouse Medical Pavillion)Columbus, Egyesült ÁllamokNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
The goal of this pilot clinical study is to investigate the NeuroLife EMG-FES Sleeve System, a closed-loop approach to functional electrical stimulation, in adults (n=12) with chronic (>12 months) tetraplegia due to spinal cord injury. Briefly, the NeuroLife EMG-FES System is a completely non-invasive system (surface electrodes only, no implantable components) worn on the forearm which has up to 160 electrodes that can record electromyography (EMG), or muscle activity, and also electrically stimulate (FES) muscles. The main questions this study aims to answer are: 1) What is the safety, feasibility, and early efficacy of the NeuroLife EMG-FES system on upper extremity outcomes in chronic SCI survivors with tetraplegia, and 2) Can EMG be used as a biomarker of recovery over time in chronic SCI participants undergoing rehabilitation? Participants will complete an intensive, task-oriented rehabilitation protocol using the NeuroLife EMG-FES System (3x/week x 12 weeks) in an outpatient setting. We will assess functional outcomes using standardized clinical measures of hand and arm function at six timepoints.
A vizsgálat csoportja
- NeuroLife EMG-FES Sleeve SystemA vizsgált kezelés
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.
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- A regiszteradat frissítve
- 2026. május 26.