40 Participants Needed

Spinal Stimulation + Gait Training for Spinal Cord Injury

(CIMELocomotion Trial)

DB
NH
Overseen ByNicolas Hoang Quang, MSc
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining spinal stimulation with gait training helps individuals with recent spinal cord injuries improve leg movement. Researchers seek to assess whether this combination is safe and enhances muscle activity more than gait training alone. Participants will either undergo regular gait training or receive it with added spinal stimulation to evaluate which method is more effective. The trial seeks individuals who have experienced a spinal injury within the past six months, can stand with or without assistance for at least 10 minutes, and can follow instructions in French or English. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance rehabilitation techniques for spinal cord injuries.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those with medications or implants that might interfere with rehabilitation or spinal stimulation. It's best to discuss your specific medications with the trial team.

What prior data suggests that this spinal stimulation with gait training is safe for individuals with spinal cord injury?

Research has shown that using transcutaneous spinal cord stimulation (tSCS) with walking exercises is generally safe for people with spinal cord injuries. In earlier studies, combining tSCS with activity-based therapy did not raise any serious safety issues. Participants experienced only minor side effects, such as skin irritation.

When tSCS was used with walking exercises, it improved walking in people with long-term spinal cord injuries. Participants accepted the treatment well, and safety information from these studies supports its use.

In summary, early findings suggest that tSCS with walking exercises is safe and may help improve movement in people with spinal cord injuries. However, individual experiences may vary, so discussing any concerns with healthcare providers before starting treatment is important.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about spinal stimulation combined with gait training for spinal cord injury because it offers a new approach to enhancing movement. While traditional treatments often focus on physical therapy alone, this method uses transcutaneous spinal cord stimulation (tSCS) to actively engage spinal circuits involved in locomotion. This stimulation is thought to facilitate voluntary movements and bolster the effects of gait training. By precisely targeting the spinal cord, the technique aims to improve walking abilities more effectively than current options, potentially leading to greater independence for individuals with spinal cord injuries.

What evidence suggests that spinal stimulation with gait training might be an effective treatment for spinal cord injury?

Research has shown that adding transcutaneous spinal cord stimulation (tSCS) to walking exercises can enhance leg movement in individuals with long-term spinal cord injuries. This trial will compare two approaches: one group will receive active tSCS combined with gait training, while another group will receive sham tSCS with gait training alone. Active stimulation activates the spinal nerves that control walking. Studies have found that combining tSCS with activity-based therapy (ABT) can improve leg recovery even more than a year after an injury. Using tSCS with walking exercises can lead to better muscle use and movement, suggesting it might also benefit those with newer injuries. Overall, tSCS is a promising method for improving movement in people with spinal cord injuries.12467

Are You a Good Fit for This Trial?

This trial is for individuals over 16 years old with a recent spinal cord injury (1 week to 6 months ago) that has resulted in paraplegia or quadriplegia. Participants must have some standing ability, understand French or English, and be able to give informed consent without cognitive impairments.

Inclusion Criteria

My spinal injury is classified between AIS A to D.
I have a spinal cord injury that occurred between 1 week and 6 months ago.
I am older than 16 years.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive gait training combined with either active or sham transcutaneous spinal cord stimulation (tSCS) for 20 sessions over approximately five weeks

5 weeks
20 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of muscle strength, spasticity, balance, and sensory function

4 weeks
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Spinal Stimulation with Gait Training

Trial Overview

The study tests if adding transcutaneous spinal cord stimulation (tSCS) to gait training helps improve leg function in people with subacute spinal cord injuries more than gait training alone. One group receives sham stimulation while the other gets effective tSCS during their walking exercises.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Gait training + tSCS (n=20)Experimental Treatment1 Intervention
Group II: Gait training alone (n=20)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Lead Sponsor

Trials
17
Recruited
3,400+

Mitacs

Industry Sponsor

Trials
46
Recruited
5,200+

Citations

Effects of transcutaneous spinal stimulation with gait training ...

Stroke survivors present with various deficits, and gait training has been reported to have a positive impact on stroke survivors.

Spinal Stimulation With Gait Training to Improve Lower ...

Recent findings suggest that adding transcutaneous spinal cord stimulation (tSCS) to ABT in chronic SCI (> 12 months) can enhance lower-limb motor recovery.

Effectiveness of Transcutaneous Spinal Cord Stimulation ...

Objective: This systematic review and meta-analysis will determine the effectiveness of tSCS, compared with sham stimulation, no intervention, ...

Safety and Effectiveness of Multisite Transcutaneous ...

Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating ...

Effectiveness of transcutaneous spinal cord stimulation for ...

Transcutaneous spinal cord stimulation (tSCS) has emerged as a promising non-invasive neuromodulation technique for improving motor function in individuals with ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39885542/

Transcutaneous spinal cord stimulation combined with ...

The outcomes of this study suggest that the combination of standard Lokomat training with tSCS for 20 sessions was effective for LEMS and gait recovery in ...

Effectiveness of Transcutaneous Spinal Cord Stimulation ...

Objective: This systematic review and meta-analysis will determine the effectiveness of tSCS, compared with sham stimula- tion, no intervention, ...