Transcutaneous Spinal Cord Stimulation for Upper Extremity Function

April 7, 2026 updated by: University of Alberta

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5G 0B7
        • Recruiting
        • Glenrose Rehabilitation Hospital
        • Contact:
      • Edmonton, Alberta, Canada, T6G-2E1
        • Recruiting
        • University of Alberta
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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).
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.
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)
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.
Baseline, End of Intervention (2mths) and at 6-month follow-up timepoint (8mths)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Glenrose Foundation

Investigators

  • Principal Investigator: Jessica D'Amico, PhD, University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2024

Primary Completion (Estimated)

September 14, 2029

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

September 10, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro001405596

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to shared IPD with other researchers. Deidentified data may be shared with a data repository.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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