Clinical trial NCT06596369: Transcutaneous Spinal Cord Stimulation for Upper Extremity Function
Official title: Transcutaneous Spinal Cord Stimulation to Facilitate Recovery of Upper Extremity Function in Individuals With Stroke or Spinal Cord Injury - A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Spinal Cord Injuries
Stroke
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Glenrose Foundation
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

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

Primary outcomes:
measure: Spinal Excitability
timeFrame: Baseline, End of Intervention (2mths), 6-month follow-up (8mths)
measure: Corticospinal excitability
timeFrame: Baseline, End of Intervention (2mths) and at 6-month follow-up timepoint (8mths)
measure: Clinical assessment of UE function
timeFrame: Baseline, End of Intervention (2mths), and 6-month Follow-up (8mths).
measure: Changes in Intracortical Excitability
timeFrame: Baseline, End of Intervention (2mths) and at 6-month follow-up timepoint (8mths)
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Glenrose Rehabilitation Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Jessica D'Amico, PhD
role: PRINCIPAL_INVESTIGATOR
References: