Recruiting

Phase 2

Phase 3

Transcutaneous Spinal Cord StimulationTranscutaneous Spinal Cord Stimulation for Upper Extremity Function

Sponsor:

University of Alberta

Code:

NCT06596369

Conditions

Spinal Cord Injuries

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous spinal cord stimulation

Upper extremity rehabilitation

Study Details

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, 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.

Conditions

Spinal Cord Injuries

Stroke

Study ID

NCT06596369

Start date

Jun 15, 2024

Status verified date

Apr, 2026

Completion date

Dec 30, 2029

Anticipated

Primary completion date

Sep 14, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: tSCS + Rehab

In this single arm study, individuals will receive transcutaneous spinal cord stimulation over the cervical spinal cord with upper extremity training utilizing the ReJoyce system.

Interventions

Transcutaneous spinal cord stimulation

Continuous, sub motor threshold stimulation is delivered through surface electrodes placed over the cervical spine region.

Upper extremity rehabilitation

Using the ReJoyce system individuals will engage in upper extremity rehabilitation.

Primary outcome measure

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) ]

Central Contacts and Locations

Central contacts

Jessica D'Amico, PhD

7807357917 damico1@ualberta.ca

Locations

Glenrose Rehabilitation Hospital

Recruiting

Edmonton, Alberta, Canada, T5G 0B7

Contacts

Jessica D'Amico, PhD

7807357917 jessica.d'amico@ahs.ca

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G-2E1

Contacts

Jessica D'Amico, PhD

780-735-7917 damico1@ualberta.ca

More Information

Sponsor

University of Alberta

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-04-13.