Exoskeleton-Assisted Walking + Spinal Cord Stimulation for Bone Loss in Spinal Cord Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to assist people with spinal cord injuries by combining exoskeleton-assisted walking with spinal cord stimulation. The main goal is to determine if this combination can improve muscle and bone health, which often deteriorates after such injuries, potentially leading to fractures and other complications. Participants will be divided into two groups: one will receive active spinal cord stimulation, and the other will receive a non-active version. The trial seeks individuals who have been unable to walk for over three years due to a spinal cord injury and rely entirely on a wheelchair. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance the quality of life for those with spinal cord injuries.
Will I have to stop taking my current medications?
The trial requires that participants are not currently taking any medications that can affect muscle and/or bone metabolism. If you are on such medications, you may need to stop taking them to participate.
What prior data suggests that this exoskeleton-assisted walking and spinal cord stimulation protocol is safe for spinal cord injury patients?
Research shows that exoskeletons are generally safe for people with mobility issues. Studies have found that they assist with walking and movement training with few problems.
For transcutaneous spinal cord stimulation (tSCS), early research suggests it is also safe when combined with activity-based therapy. One study found that using tSCS with exoskeletons was well-tolerated by people with spinal cord injuries (SCI).
Overall, both exoskeleton-assisted walking and tSCS have been researched and are considered safe for people with SCI. No major reports of serious side effects have emerged.12345Why are researchers excited about this trial?
Researchers are excited about combining exoskeleton-assisted walking with spinal cord stimulation because it offers a unique way to tackle bone loss in spinal cord injury patients. Unlike typical treatments that might focus solely on medication or physical therapy, this approach integrates advanced technology to enhance movement and stimulate the spine simultaneously. The active spinal cord stimulation aims to reawaken nerve pathways, potentially leading to greater improvements in bone density. This dual-action method brings hope for not just managing symptoms but also possibly reversing some of the bone loss effects associated with spinal cord injuries.
What evidence suggests that this trial's treatments could be effective for bone loss in spinal cord injury?
Research shows that using an exoskeleton to help people with spinal cord injuries (SCI) walk can improve muscle strength and bone health. Studies have found that walking with an exoskeleton increases muscle activity and bone density, which often decrease after an SCI. Additionally, transcutaneous spinal cord stimulation (tSCS) uses electrical currents to stimulate the spinal cord, activating muscles and improving blood flow. This trial will compare two approaches: one group will receive exoskeleton-assisted walking combined with active tSCS, while another group will receive exoskeleton-assisted walking with sham tSCS. Early research suggests that combining exoskeleton walking with active tSCS might enhance these benefits, possibly reversing some muscle and bone loss. Although this method remains under study, the goal is to improve overall muscle and bone health in people with SCI.12678
Who Is on the Research Team?
Christopher P Cardozo, M.D.
Principal Investigator
James J. Peters VA Medical Center
Are You a Good Fit for This Trial?
This trial is for individuals with chronic spinal cord injury who have experienced muscle and bone loss. Participants should be in a stable condition to undergo exoskeleton-assisted walking training. Those with certain medical conditions that could interfere with the study or pose a risk during physical activity are not eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive exoskeleton-assisted walking (EAW) training combined with either active or sham transcutaneous spinal cord stimulation (tSCS) for 108 sessions over 36 weeks
Midpoint Assessment
Imaging and EMG assessments are conducted to evaluate muscle and bone health after approximately 54 training sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation
Trial Overview
The study tests if adding transcutaneous spinal cord stimulation (tSCS) to exoskeleton-assisted walking (EAW) improves muscle and bone health more than EAW alone. Participants will be randomly assigned to receive either active tSCS or sham (inactive) treatment alongside EAW.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
The EAW + active tSCS group will receive simultaneous lumbosacral tSCS while simultaneously performing EAW.
The EAW + sham tSCS group will receive simultaneous lumbosacral sham tSCS while simultaneously performing EAW. Participants in both groups will receive 60 minutes of EAW + sham tSCS overground training per session for a total of 108 sessions (3 X week for 36 weeks).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bronx VA Medical Center
Lead Sponsor
Kessler Foundation
Collaborator
Citations
The Effect of Exoskeletal-assisted Walking Combined With ...
This study will compare the effect of exoskeleton-assisted walking (EAW) training combined with transcutaneous spinal cord stimulation (tSCS) ( ...
Exoskeletal-assisted walking combined with transcutaneous ...
This paper describes a research protocol to compare the effect of exoskeletal-assisted walking (EAW) alone versus EAW plus transcutaneous spinal cord ...
study protocol for a prospective randomised controlled trial
This paper describes a research protocol to compare the effect of exoskeletal-assisted walking (EAW) alone versus EAW plus transcutaneous spinal cord ...
The design of a randomized control trial of exoskeletal ...
The design of a randomized control trial of exoskeletal-assisted walking in the home and community on quality of life in persons with chronic ...
Exoskeleton and Spinal Cord Stimulation for SCI
The overall aim of this project is to assess the effect of combining transcutaneous lumbosacral stimulation (TLS) during Exoskeleton Assisted Walking (EAW) ...
Safety and Effectiveness of Multisite Transcutaneous ...
Evaluate the preliminary safety and efficacy of multi-site transcutaneous spinal cord stimulation (tSCS) combined with activity-based therapy (ABT) in ...
Exoskeleton Walk Training in Paralyzed Individuals ...
Exoskeletons (Exo) have been shown to enable over-ground weighted walking and gait training for the mobility impaired persons, particularly for ...
Full article: Priming with transcutaneous spinal direct ...
The study demonstrated the safety of spinal cord priming with repeated tsDCS for individuals with SCI in combined with exoskeleton-assisted ...
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