Spinal Cord Stimulation for Spinal Cord Injury
(CIME_upperlimb Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if adding spinal cord stimulation, a non-invasive technique, to activity-based therapy can improve arm and hand movement in individuals with cervical spinal cord injuries. Researchers seek to understand if this combination is more effective than therapy alone and whether it induces changes in the brain and spinal cord that aid movement. Participants will receive either real spinal stimulation or a low-intensity sham version, alongside therapy sessions to monitor improvements. The trial seeks individuals who have experienced a spinal cord injury affecting their arms and legs within the past six months and who retain some arm movement. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance rehabilitation strategies for spinal cord injuries.
What prior data suggests that this combination of activity-based therapy and transcutaneous spinal cord stimulation is safe for improving arm and hand movement in people with cervical spinal cord injury?
Research has shown that non-invasive spinal cord stimulation is safe for people with neck spinal cord injuries. Studies indicate that this therapy can improve hand and arm functions without causing serious side effects. One study highlighted that ARC EX Therapy, a type of stimulation, is both safe and effective. The Up-LIFT Trial supported these findings, showing that adding spinal cord stimulation to rehabilitation is safe. Therefore, combining this stimulation with activity-based therapy appears well-tolerated and aids in arm and hand recovery.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores non-invasive spinal cord stimulation combined with activity-based therapy to improve upper limb function after spinal cord injury. Unlike traditional rehabilitation methods that primarily focus on physical exercises, this approach uses transcutaneous spinal cord stimulation (tSCS), which applies electrical stimulation through the skin to potentially enhance nerve activity and muscle control. The trial compares sham stimulation, which mimics the process without actual stimulation, to real-intensity stimulation, providing valuable insights into tSCS's effectiveness in facilitating recovery. This could lead to new, less invasive treatment options for individuals with spinal cord injuries, offering hope for improved mobility and quality of life.
What evidence suggests that the ABT + tSCS combination is effective for improving arm and hand movement in cervical spinal cord injury?
Research has shown that transcutaneous spinal cord stimulation (tSCS) combined with activity-based therapy (ABT) may improve hand and arm function in individuals with cervical spinal cord injury (SCI). One study found that 72% of participants experienced significant improvements in upper limb movement using this method. In the current trial, participants will be randomized into different groups: one receiving real-intensity tSCS with ABT, and another receiving sham tSCS with ABT. Other studies indicate that tSCS can aid in some nerve recovery, though improvements might be small. This treatment is safe and can enhance arm use in everyday activities. Early findings suggest that combining tSCS with ABT might cause changes in the brain and spinal cord, potentially enhancing recovery.15678
Who Is on the Research Team?
Dorothy Barthelemy, pht., PhD
Principal Investigator
Université de Montréal
Are You a Good Fit for This Trial?
This trial is for individuals with cervical spinal cord injury, including conditions like quadriplegia. Participants should be in the sub-acute stage post-injury and able to commit to a 6-8 week therapy program. Specific inclusion and exclusion criteria details are not provided.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either ABT + tSCS or ABT + sham stimulation over 20 sessions in 6-8 weeks
Neurophysiological Assessment
Clinical tests and neurophysiological assessments conducted at three time points to measure recovery and brain activity changes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Upper Limb Rehabilitation Using Non-invasive Spinal Cord Stimulation
Trial Overview
The study tests if activity-based therapy (ABT) combined with transcutaneous spinal cord stimulation (tSCS) improves arm/hand movement more than ABT alone after a cervical SCI. It also examines neuroplasticity effects and daily life arm usage.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants with cervical spinal cord injury (ASIA levels A-D) randomized to this arm will receive real-intensity transcutaneous spinal cord stimulation combined with activity-based therapy. Training will consist of 20 sessions delivered over 6-8 weeks during the subacute stage. For the transcutaneous spinal cord stimulation (tSCS), a single or two self-adhesive cathode electrodes will be placed at the C4 to T1 vertebral levels. A pair of reference electrodes will be placed bilaterally on the external part of the clavicular regions. The stimulation will be set at minimal intensity, sufficient only for the participants to perceive it. Individualized tSCS parameters (30-80Hz, 0-90mA, biphasic 400us pulse square) will be used to facilitate upper limb movement.
Participants with cervical spinal cord injury (ASIA levels A-D) randomized to this arm will receive sham transcutaneous spinal cord stimulation combined with activity-based therapy. Training will consist of 20 sessions delivered over 6-8 weeks during the subacute stage. For the transcutaneous spinal cord stimulation (tSCS), a single or two self-adhesive cathode electrodes will be placed at the C4 to T1 vertebral levels. A pair of reference electrodes will be placed bilaterally on the external part of the clavicular regions. The stimulation will be set at minimal intensity, sufficient only for the participants to perceive it.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Lead Sponsor
Citations
Non-invasive Transcutaneous Spinal Cord Stimulation ...
This study analyzes the stimulation parameters implemented during two successful trials that used non-invasive transcutaneous spinal cord stimulation (tSCS)
Non-invasive Transcutaneous Spinal Cord Stimulation ...
This study analyzes the stimulation parameters implemented during two successful trials that used non-invasive transcutaneous spinal cord stimulation (tSCS)
Non-invasive spinal cord electrical stimulation for arm and ...
These results demonstrate the safety and efficacy of ARC EX Therapy to improve hand and arm functions in people living with cervical SCI.
tESCS for Upper Limb Rehab in Spinal Cord Injury
The results are showing some neurological recovery but modest functional improvement, indicating that some minimal level of preserved sensory or motor function ...
Home-Based Noninvasive Spinal Cord Stimulation Safely ...
Recently, the Up-LIFT Trial (NCT04697472) found that 72% of participants experienced clinically meaningful improvements in upper extremity ...
Upper Limb Spinal Cord Stimulation for Rehabilitation ...
We are investigating the effect of adding non-invasive SCS to inpatient rehabilitation on upper limb function for people with acute SCI. We will test this ...
Non-invasive spinal cord electrical stimulation for arm and ...
These results demonstrate the safety and efficacy of ARC EX Therapy to improve hand and arm functions in people living with cervical SCI.
Upper Limb Spinal Cord Stimulation for Rehabilitation ...
We are investigating the effect of adding non-invasive SCS to inpatient rehabilitation on upper limb function for people with acute SCI. We will test this ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.