Transcutaneous Spinal Cord Stimulation for Upper Extremity Function

Launched by UNIVERSITY OF ALBERTA · Sep 10, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called transcutaneous electrical stimulation (tcES) to help people with upper limb difficulties caused by spinal cord injuries or strokes. The goal is to understand how different settings of this non-invasive stimulation can improve nerve activity and, ultimately, help patients regain better use of their arms and hands. Researchers are looking for participants aged 18 to 75 who have experienced a spinal cord injury at the neck level or a stroke that has affected their arm movement, as long as they meet specific health criteria.

Participants in the trial will undergo evaluations to see how well the tcES works during certain motor tasks. This means they will be asked to perform activities while receiving the stimulation, allowing researchers to gather important information about its effects. It's essential to note that pregnant women and individuals with certain medical devices or conditions will not be eligible for this study. By participating, individuals may contribute to valuable knowledge that could lead to new treatments for improving upper extremity function in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• SCI cohort:
• • 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
• Exclusion Criteria:
• • 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