Home-Based Digital Rehabilitation Program Optimized With Transcutaneous Spinal Cord Stimulation for Upper Limb Functional Enhancement in Tetraplegia (HOPE): A Safety, Efficacy, and Feasibility Study

Who can take part

• Participant
• Age 21 -75 years
• Non-progressive cervical SCI/spinal cord dysfunction (traumatic or non-traumatic)
• Duration of SCI/spinal cord dysfunction more than or equal to 12 months
• ASIA Impairment scale (AIS B, C, or D) with impaired upper limb function
• At least one hand capable of grasp and pinch, with or without assistive modification
• International Standards for Neurological Classification of Spinal Cord Injury-Upper Extremity Measurement Scale (ISNCSCI-UEMS) more than or equal to 20
• Able to maintain an upright sitting position for at least 30 minutes
• No contraindication for tSCS (e.g., no pacemakers or other implantable stimulators)
• Motivated and able to engage in a daily home-based rehabilitation program
• Availability of a dedicated care-giver to set up digital home-based therapy program; Caregiver
• Age 21 -75 years
• As identified by the patient as the caregiver
• Willing to participate in the study

Who cannot take part

• Prior exposure to tSCS treatment
• Significant or unstable medical co-morbidities including uncontrolled cardiopulmonary disease, severe cognitive impairment, severe dysautonomia, as determined by the investigator
• History of other neurologic conditions affecting upper limb function, such as stroke, multiple sclerosis, or traumatic brain injury
• Known history of peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc)
• Ongoing treatment for cancer
• Skin conditions or active cancerous lesion that limit the application of tSCS electrodes
• Participant
• Pregnancy
• Known contraindication for tSCS (pacemakers or other implantable stimulators)
• Inability to provide informed consent; Caregiver:
• Inability to provide informed consent