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Eine Studie entspricht den Filterkriterien
Kartenansicht
Feasibility of Home Based Transcutaneous Spinal Cord Stimulation for Persons With SCI
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06140706 ist eine interventionsstudie zur Untersuchung von Tetraplegie und hat den Status noch nicht rekrutierend. Der Start ist für 1. September 2025 geplant, bis 10 Teilnehmer aufgenommen werden. Durchgeführt von VA Palo Alto Health Care System wird der Abschluss für 31. Dezember 2027 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 10. April 2025 aktualisiert.
Kurzbeschreibung
The proposed study will focus on the feasibility of and effectiveness to a home-based program for persons with chronic SCI focused on upper limb training augmented with a transcutaneous neurostimulator supported via a video telehealth platform.
Ausführliche Beschreibung
The overarching goal of this study is to train participants with tetraplegia and their companion to operate a non-invasive surface applied neurostimulation unit (ONWARD, ARCex) while performing a prescriptive functional task based upper extremity home program for 2 months. Participants will be supported with video-telehealth to assist with any difficulties that may arise and to progress their upper extremity home program. Evaluations will assess the feasibility of this video telehealth supported model as measured by the ease of use of the technology (QUEST 2.0, NASA-TLX) as well as participants ability to attend and complete all the training visits. Changes in upper extremity physical function will be measured using validated clinical tools (GRASSP, CUE-Q, DASH, COPM) as well as detailed evaluation of upper extremity muscle activation from surface EMG and strength measurements of pinch and grasp.
The primary outcome measure of this study is feasibility, and the secondary outcome measure is to capture changes in upper extremity performance.
Offizieller Titel
Feasibility of a Video Telehealth Model to Evaluate Home Use of Transcutaneous Spinal Cord Stimulation for Enhanced Upper Limb Function
Erkrankungen
TetraplegieWeitere Studien-IDs
- IRB-68905
NCT-Nummer
Studienbeginn (tatsächlich)
2025-09-01
Zuletzt aktualisiert
2025-04-10
Studienende (vorauss.)
2027-12-31
Geplante Rekrutierung
10
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Noch nicht rekrutierend
Stichwörter
paralysis
exercise
telemedicine
spinal cord stimulation
physical activity
exercise
telemedicine
spinal cord stimulation
physical activity
Primäres Ziel
Andere
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentelltSCS plus home tele-video support Cervical transcutaneous spinal stimulation during home tele-video visits | Transcutaneous Spinal Cord Stimulation (TSCS) Neurostimulation for upper extremity training, delivered through video telehealth, 8 weeks of home use for (i) feasibility and (ii) potential functional improvement. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
NASA-TLX (NASA Task Load Index) | Measures subjective mental work load \& physical effort | At 8 weeks (after completion of home program) |
QUEST 2.0 (Quebec User Evaluation of Satisfaction with assistive Technology) | Measures usability of device (eg, adjustability, comfort, safety and effectiveness) | At 8 weeks (after completion of home program) |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
GRASSP (The Graded Redefined Assessment of Strength Sensibility and Prehension) | Measures upper limb sensation, strength, and prehension | At entry (Baseline) and repeated at 8 weeks (after completion of home program) |
CUE-Q (Capabilities of Upper Extremity Function) | Measures functional limitation and difficulty in performing upper limb activities | At entry (Baseline) and repeated at 8 weeks (after completion of home program) |
DASH (Disabilities of the Arm, Shoulder, and Hand) | Measures upper limb function during ADL tasks, work activities, recreational sports, and pain-related limitations | At entry (Baseline) and repeated at 8 weeks (after completion of home program) |
COPM (Canadian Occupational Performance Measure) | Measures performance \& satisfaction of self-identified activities in self-care, productivity and leisure | At entry (Baseline) and repeated at 8 weeks (after completion of home program) |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- Veteran
- Age 18-65
- All gender, any ethnicity
- Cervical Spinal Cord Injury C2-8
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) B, C or D
- GRASSP-Prehension Score >10 or GRASSP Strength Score >30
- Greater than 1 year post injury
- Able to identify a companion to assist with neurostimulator setup in home environment.
- Internet connection to support video telehealth connection
- Willingness to travel to the VA Palo Alto Medical Center
- Cardiopulmonary disease or cardiac symptoms,
- Autonomic dysreflexia that is uncontrolled or severe,
- Implanted medical device(s),
- Uncontrolled spasms that could limit participation in exercise training,
- Skin breakdown or active pressure injury in areas of electrode placement.
- Participants must not be engaged in any concurrent drug or device trial
- Pregnant, are planning to become pregnant, or breastfeeding
- The study is not deemed safe or appropriate in the opinion of the investigators
VA Palo Alto Health Care SystemONWARD Medical, Inc.Verantwortliche Partei
Beatrice Jenny Kiratli PhD, Hauptprüfer, Research Health Scientist, VA Palo Alto Health Care System
Zentrale Studienkontakte
Kontakt: Jeffrey Jaramillo, DPT, 650-493-5000, [email protected]
Kontakt: Jenny Kiratli, PhD, 650-493-5000, [email protected]
1 Studienstandorte in 1 Ländern
California
VA Palo Alto Health Care System, Palo Alto, California, 94304, United States