Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06140706
Study type Interventional
Source VA Palo Alto Health Care System
Contact Jeffrey Jaramillo, DPT
Phone 650-493-5000
Email jeffrey.jaramillo@va.gov
Status Not yet recruiting
Phase N/A
Start date January 1, 2024
Completion date December 31, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT04736849 - Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury N/A
Terminated NCT03513783 - Elbow Extension Restoration Surgery in People With Tetraplegia: Evolution of the Muscular Co-activations of the Upper Limb During the Post-operative Rehabilitation N/A
Recruiting NCT05432999 - Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury N/A
Completed NCT03698136 - Electrical Stimulation in Denervated Muscles of the Upper Limbs N/A
Recruiting NCT05553457 - MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury N/A
Completed NCT04020770 - Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia N/A
Completed NCT04964635 - TETRAGRIP II - Usability Trial of an FES Orthosis for People With Tetraplegia. N/A
Recruiting NCT06094205 - Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02) N/A
Enrolling by invitation NCT02602639 - Functional Electrical Stimulation With Rowing as Exercise After Spinal Cord Injury N/A
Completed NCT01467856 - Sleep Disordered Breathing N/A
Completed NCT00385918 - Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI) N/A
Recruiting NCT05724173 - Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia N/A
Completed NCT05555914 - Neural Stimulation for Hand Grasp in People With Tetraplegia N/A
Completed NCT03975075 - Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury N/A
Recruiting NCT01474148 - A Neuroprosthesis for Seated Posture and Balance N/A
Active, not recruiting NCT03811301 - [BrainConnexion] - Neurodevice Phase I Trial N/A
Terminated NCT01498991 - Spinal Cord Injury Leg Rehabilitation Phase 1/Phase 2
Completed NCT03237091 - Enhancing Corticospinal Excitability to Improve Functional Recovery N/A
Recruiting NCT05665998 - Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation N/A
Completed NCT01393444 - ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis N/A