Transcutaneous Spinal Cord Stimulation for Upper Extremity Function

NCT06596369 | Recruiting Phase 2

• 1 other identifier: Pro001405596
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline, End of Intervention (2mths) and at 6-month follow-up timepoint (8mths)

Study Arms (1)

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.

Device: Transcutaneous spinal cord stimulation; Other: Upper extremity rehabilitation

Interventions

Transcutaneous spinal cord stimulation DEVICE

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

tSCS + Rehab

Upper extremity rehabilitation OTHER

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

tSCS + Rehab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnant women
• aphasia or dysphasia
• spasticity grade Modified Ashworth Scale ≥ 3
• 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

Sponsors & Collaborators

• University of Alberta: lead
• Glenrose Foundation: collaborator

Study Sites (2)

Glenrose Rehabilitation Hospital

Edmonton, Alberta, T5G 0B7, Canada

RECRUITING

University of Alberta

Edmonton, Alberta, T6G-2E1, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Stroke

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jessica D'Amico, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica D'Amico, PhD

CONTACT

7807357917; damico1@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: September 19, 2024
• Study Start: June 15, 2024
• Primary Completion (Estimated): September 14, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)