Status:
RECRUITING
Transcutaneous Spinal Cord Stimulation for Upper Extremity Function
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Glenrose Foundation
Conditions:
Spinal Cord Injuries
Stroke
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
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, epidur...
Detailed Description
In the first two aims of this study we explore the effects of stimulation configurations on neural excitability. Specifically we will explore the effects of electrode placement and stimulation frequen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06596369
Start Date
June 15 2024
End Date
December 30 2029
Last Update
March 27 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Glenrose Rehabilitation Hospital
Edmonton, Alberta, Canada, T5G 0B7
2
University of Alberta
Edmonton, Alberta, Canada, T6G-2E1