Transcutaneous Spinal Cord Stimulation for Upper Extremity Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutaneous spinal cord stimulation, Upper extremity rehabilitation.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries, Stroke. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transcutaneous Spinal Cord Stimulation to Facilitate Recovery of Upper Extremity Function in Individuals With Stroke or Spinal Cord Injury - A Pilot Study
Overview
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.
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 frequency on measures of corticospinal and intracortical excitability. In the last aim of this study, individuals will participate in an interventional trial combining activity-based therapy with tcES. We will explore whether this intervention facilitated improvements in upper extremity function through clinical and neurophysiological assessments.
Interventions
- Device Transcutaneous spinal cord stimulation
Continuous, sub motor threshold stimulation is delivered through surface electrodes placed over the cervical spine region. - Other Upper extremity rehabilitation
Using the ReJoyce system individuals will engage in upper extremity rehabilitation.
Primary outcome measures
- Spinal Excitability [Time frame: Baseline, End of Intervention (2mths), 6-month follow-up (8mths)]
- Corticospinal excitability [Time frame: Baseline, End of Intervention (2mths) and at 6-month follow-up timepoint (8mths)]
- Clinical assessment of UE function [Time frame: Baseline, End of Intervention (2mths), and 6-month Follow-up (8mths).]
- Changes in Intracortical Excitability [Time frame: Baseline, End of Intervention (2mths) and at 6-month follow-up timepoint (8mths)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Canada · 2 centers
- Glenrose Rehabilitation Hospital — Edmonton
- University of Alberta — Edmonton
Identifiers
NCT: NCT06596369 · Pro001405596