Transcutaneous Spinal Cord Stimulation for Upper Extremity Function

NCT ID: NCT06596369

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-15
• Study Completion Date: 2029-12-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcutaneous spinal cord stimulation

Intervention Type: DEVICE

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

Upper extremity rehabilitation

Intervention Type: OTHER

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

Interventions

Transcutaneous spinal cord stimulation

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

Intervention Type: DEVICE

Upper extremity rehabilitation

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

Intervention Type: OTHER

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glenrose Foundation

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica D'Amico, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Glenrose Rehabilitation Hospital

Edmonton, Alberta, Canada

Site Status: RECRUITING

University of Alberta

Edmonton, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jessica D'Amico, PhD

Role: CONTACT

damico1@ualberta.ca

7807357917

Facility Contacts

Jessica D'Amico, PhD

Role: primary

jessica.d'amico@ahs.ca

7807357917

Jessica D'Amico, PhD

Role: primary

damico1@ualberta.ca

780-735-7917

Other Identifiers

Pro001405596

Identifier Type: -

Identifier Source: org_study_id