RecruitingPhase 2Phase 3NCT06596369

Transcutaneous Spinal Cord Stimulation for Upper Extremity Function

Transcutaneous Spinal Cord Stimulation to Facilitate Recovery of Upper Extremity Function in Individuals With Stroke or Spinal Cord Injury - A Pilot Study


Sponsor

University of Alberta

Enrollment

30 participants

Start Date

Jun 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria10

  • 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 Criteria7

  • 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

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Interventions

DEVICETranscutaneous spinal cord stimulation

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

OTHERUpper extremity rehabilitation

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


Locations(2)

Glenrose Rehabilitation Hospital

Edmonton, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

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NCT06596369


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