Spinal Cord InjuriesPhase 2/3NCT06596369
Transcutaneous Spinal Cord Stimulation for Upper Extremity Function
A Phase 2/3 study testing Transcutaneous spinal cord stimulation and Upper extremity rehabilitation in people with Spinal Cord Injuries and Stroke, run by University of Alberta at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries, Stroke
- What is being tested?
- Transcutaneous spinal cord stimulation and Upper extremity rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- 15 Jun 2024to 30 Dec 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G 0B7
Jessica D'Amico, PhD, 7807357917, jessica.d'amico@ahs.ca
- Recruiting
University of Alberta
Edmonton, Alberta, T6G-2E1
Jessica D'Amico, PhD, 780-735-7917, damico1@ualberta.ca
About this study
Official title: Transcutaneous Spinal Cord Stimulation to Facilitate Recovery of Upper Extremity Function in Individuals With Stroke or Spinal Cord Injury - A Pilot Study
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Stroke
- Being tested
- Transcutaneous spinal cord stimulation, Upper extremity rehabilitation
- Medical subject headings
- Spinal Cord Injuries, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous spinal cord stimulationDevice
Continuous, sub motor threshold stimulation is delivered through surface electrodes placed over the cervical spine region.
Upper extremity rehabilitationOther
Using the ReJoyce system individuals will engage in upper extremity rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| tSCS + Rehab | Experimental | 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. Receives: Device: Transcutaneous spinal cord stimulation; Other: Upper extremity rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal Excitability
Changes in spinal excitability measured by stimulating the cervical spinal cord while recording muscle signals from upper extremity muscles will be assessed at the beginning and end of the interventional arm, and then 6 months following completion of the intervention.
Measured: Baseline, End of Intervention (2mths), 6-month follow-up (8mths)
Corticospinal excitability
Changes in corticospinal excitability (using transcranial magnetic stimulation) will be assessed at the beginning and end of the interventional arm, and then 6 months following completion of the intervention.
Measured: Baseline, End of Intervention (2mths) and at 6-month follow-up timepoint (8mths)
Clinical assessment of UE function
For SCI participants, the GRASSP assessment will be utilized to assess changes in upper extremity strength, sensation and function. In the stroke population, the ARAT, Fugl-Meyer tests will be utilized. In both patient groups, the arm and hand function test performed by the ReJoyce system will also be utilized.
Measured: Baseline, End of Intervention (2mths), and 6-month Follow-up (8mths).
Changes in Intracortical Excitability
Changes in intracortical excitability utilizing paired-pulse transcranial magnetic stimulation protocols will be explored at baseline, end of the intervention period, and 6months following completion of the trial.
Measured: Baseline, End of Intervention (2mths) and at 6-month follow-up timepoint (8mths)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Jun 2024
- Primary completion14 Sep 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Glenrose Foundation
- Responsible party
- Sponsor
- Investigators
- Jessica D'Amico, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596369
- Sponsor's protocol ID
- Pro001405596
- Status last verified
- Apr 2026
- First submitted
- 6 Jun 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to shared IPD with other researchers. Deidentified data may be shared with a data repository.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Cord Stimulation to Facilitate Recovery of Upper Extremity Function in Individuals With Stroke or Spinal Cord Injury - A Pilot Study
- ClinicalTrials.gov ID
- NCT06596369
- Acronym / sponsor ID
- Pro001405596
- Conditions
- Spinal Cord Injuries, Stroke
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Glenrose Foundation
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 14 Sep 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tSCS + Rehab | Experimental | Device: Transcutaneous spinal cord stimulation, Other: Upper extremity rehabilitationIn this single arm study, individuals will receive transcutaneous spinal cord stimulation over the cervical spinal cord with upper extremity training utilizing the ReJoyce system. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous spinal cord stimulationContinuous, sub motor threshold stimulation is delivered through surface electrodes placed over the cervical spine region. | Device | tSCS + Rehab |
| Upper extremity rehabilitationUsing the ReJoyce system individuals will engage in upper extremity rehabilitation. | Other | tSCS + Rehab |
Primary outcome
Spinal Excitability
Time frame: Baseline, End of Intervention (2mths), 6-month follow-up (8mths)
Changes in spinal excitability measured by stimulating the cervical spinal cord while recording muscle signals from upper extremity muscles will be assessed at the beginning and end of the interventional arm, and then 6 months following completion of the intervention.
Corticospinal excitability
Time frame: Baseline, End of Intervention (2mths) and at 6-month follow-up timepoint (8mths)
Changes in corticospinal excitability (using transcranial magnetic stimulation) will be assessed at the beginning and end of the interventional arm, and then 6 months following completion of the intervention.
Clinical assessment of UE function
Time frame: Baseline, End of Intervention (2mths), and 6-month Follow-up (8mths).
For SCI participants, the GRASSP assessment will be utilized to assess changes in upper extremity strength, sensation and function. In the stroke population, the ARAT, Fugl-Meyer tests will be utilized. In both patient groups, the arm and hand function test performed by the ReJoyce system will also be utilized.
Changes in Intracortical Excitability
Time frame: Baseline, End of Intervention (2mths) and at 6-month follow-up timepoint (8mths)
Changes in intracortical excitability utilizing paired-pulse transcranial magnetic stimulation protocols will be explored at baseline, end of the intervention period, and 6months following completion of the trial.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. We do not plan to shared IPD with other researchers. Deidentified data may be shared with a data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica D'Amico, PhD principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Transcutaneous spinal cord stimulation and Upper extremity rehabilitation in people with Spinal Cord Injuries and Stroke, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica D'Amico, PhD (7807357917, damico1@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal Excitability (time frame: Baseline, End of Intervention (2mths), 6-month follow-up (8mths)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.