Transcutaneous Spinal Cord Stimulation for Upper Extremity Function

What this study is about

Transcutaneous electrical stimulation (tcES) of the spinal cord has shown great promise in restoring upper extremity function after spinal cord injury (SCI). More recently, the use of invasive, epidural electrical stimulation of the spinal cord has also demonstrated promise in restoring upper extremity function post-stroke. However, the effect of stimulation parameters such as electrode configuration and stimulation frequency on excitability of the nervous system remains unknown preventing the opportunity to fully exploit this noninvasive stimulation paradigm. Additionally, the utility of noninvasive tcES in the stroke population remains unexplored. This project utilizes a comprehensive set of neurophysiological techniques, in combination with carefully chosen motor tasks, to directly link and assess the effects of stimulation parameters on neural excitability and upper extremity function during and following the delivery of cervical tcES in individuals with SCI and stroke. The fundamental knowledge gained from this project will ultimately improve the implementation of this novel and non-invasive neuromodulatory tool through an improved understanding of how tcES can facilitate recovery of function.

Who can join (things the study team will check)

✅ You may be able to join if…

• individuals aged 18 to 75 years of age who have suffered a spinal cord injury
• cervical level injury (C3 to C8)
• at least 1-year post-injury
• for individuals taking medications for spasmolysis or muscle relaxation (e.g. oral baclofen, tizanidine, dantrolene, vigabatrin, gabapentin, or benzodiazepine), dose and regimen must be stable for at least 4 weeks prior to screening Stroke cohort:
• individuals aged 18-75 years of age who have suffered any type of stroke resulting in upper extremity motor dysfunction with partially preserved motor function
• ≥ 6 months post-stroke
• At least 4 months since last BoNT injection for treatment of spasticity or any other condition or ≤ 2 months after study completion
• for individuals taking medications for spasmolysis or muscle relaxation (e.g. oral baclofen, tizanidine, dantrolene, vigabatrin, gabapentin, or benzodiazepine), dose and regimen must be stable for at least 4 weeks prior to screening

🚫 You may not be able to join if…

• pregnant women
• aphasia or dysphasia
• spasticity grade Modified Ashworth Scale ≥ 3 Transcranial magnetic stimulation-specific exclusion criteria (both cohorts)
• participants with active or inactive implants including cardiac pacemakers, implantable defibrillators, ocular implants, deep brain stimulators, vagus nerve stimulator, and implanted medication pumps
• participants with conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head
• participants with a history of seizures or epilepsy
• participants taking any medication which may reduce seizure threshold

Where this trial is running

• Glenrose Rehabilitation Hospital, Edmonton, Alberta, Canada
• University of Alberta, Edmonton, Alberta, Canada

Who to contact

Jessica D'Amico, PhD · 7807357917 · damico1@ualberta.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06596369.