12 Participants NeededMy employer runs this trial

Standing + Tibial Nerve Stimulation for Spinal Cord Injury

YS
Overseen ByYao Sun, PhD
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 explores how a therapy combining standing and tibial nerve stimulation can improve pelvic floor muscle function and urogenital health in individuals with chronic spinal cord injuries (SCI). Researchers aim to determine if these therapies can alter muscle reflexes and enhance quality of life for those with SCI. The trial involves a 12-week program with assessments conducted before and after the treatment. It targets adults who have had a spinal cord injury between C7 and T10 for over a year and experience bladder issues related to their injury. As an unphased trial, it offers a unique opportunity to contribute to pioneering research that could enhance treatment options for SCI-related bladder issues.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have changed your bladder management program recently or plan to receive certain injections, you may not be eligible to participate.

What prior data suggests that this method is safe for individuals with spinal cord injury?

Research has shown that transcutaneous tibial nerve stimulation (TTNS) is generally safe for people with spinal cord injuries. In earlier studies, participants used TTNS without any reported negative effects, indicating that the treatment is well-tolerated. Another study found TTNS both safe and practical during rehabilitation for those with spinal cord injuries, increasing confidence that TTNS won't cause harmful side effects.

Overall, the available evidence supports TTNS as a safe option for spinal cord injury patients, with no serious side effects reported in the studies.12345

Why are researchers excited about this trial?

Researchers are excited about the combination of standing and tibial nerve stimulation for spinal cord injury because it offers a unique approach that could enhance recovery. Unlike traditional treatments that focus mainly on rehabilitation exercises and medications to manage symptoms, this method directly stimulates the nervous system, potentially promoting nerve regeneration and improving motor function. This innovative approach not only targets the physical aspect of standing but also integrates nerve stimulation to activate pathways that could accelerate recovery and improve outcomes for individuals with spinal cord injuries.

What evidence suggests that this method is effective for spinal cord injury?

This trial will evaluate the combination of Standing and Tibial Nerve Stimulation for individuals with spinal cord injuries. Studies have shown that tibial nerve stimulation, which uses electrical signals on the lower leg, can improve bladder control and overall quality of life. Research indicates that this therapy is safe and suitable for use during rehabilitation. Some studies suggest it may also prevent bladder problems that could harm the kidneys, a common concern for those with spinal cord injuries. Additionally, combining tibial nerve stimulation with standing therapy might enhance muscle function, posture, and balance. Overall, evidence supports the potential benefits of tibial nerve stimulation in improving certain functions and daily life for people with spinal cord injuries.23678

Are You a Good Fit for This Trial?

This trial is for adults at least 19 years old with a spinal cord injury between C7 and T10 that happened over a year ago, who have bladder symptoms due to their injury. Participants must be able to use a standing frame and speak English. People with certain medical devices, unstable injuries, recent botox injections, or other serious health issues can't join.

Inclusion Criteria

I am at least 19 years old.
I meet the safety requirements to use a standing frame.
I have a spinal cord injury that affects my movement.
See 3 more

Exclusion Criteria

I have had or plan to have a Botulinum toxin-A injection in my urinary tract recently.
Have an implanted metallic or electronic device (e.g. pacemaker, nerve stimulator)
I have a spinal cord injury or tumor that is not stable.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week intervention of combined standing and tibial nerve stimulation therapy

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pelvic floor muscle reflex excitability and quality of life

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Standing + Tibial Nerve Stimulation

Trial Overview

The study tests if combining tibial nerve stimulation (a mild electrical therapy on the lower leg) with standing therapy can improve pelvic floor muscle function and urinary symptoms in people with chronic spinal cord injury. The intervention lasts 12 weeks and includes before-and-after assessments.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Standing + Tibial Nerve StimulationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials
1,506
Recruited
2,528,000+

The Craig H. Neilsen Foundation

Collaborator

Trials
62
Recruited
3,100+

Citations

Electrical stimulation for the treatment of spinal cord injuries

These studies demonstrate the promising efficacy of PNS following SCI to improve outcomes beyond motor function, representing meaningful improvements in quality ...

Utilizing Neuromodulation in the Treatment of Spinal Cord ...

Of the 33 trials, 8 were completed and 1 had published results. Most trials studied deficits of motor function (60%) and bladder control (37%). Fourteen studies ...

Transcutaneous Tibial Nerve Stimulation in Acute Spinal ...

The primary outcome of this study is the success of TTNS to prevent neurogenic DO jeopardizing the upper urinary tract, assessed by urodynamics at 1 year after ...

Safety, Feasibility, and Efficacy of Transcutaneous Tibial ...

Objectives: We investigated whether transcutaneous tibial nerve stimulation (TTNS) in acute spinal cord injury was safe and.

Epidural Stimulation and Resistance Training (REST-SCI) ...

Results: The restoration of locomotion with ES and EAW may result in a reduction in psychosocial, cardiovascular, and metabolic bladder parameters and ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30284350/

Safety, Feasibility, and Efficacy of Transcutaneous Tibial ...

TTNS is a safe and feasible modality that can be performed during inpatient rehabilitation of acute traumatic spinal cord injury.

Development and Clinical Evaluation of Spring-Assisted ...

Results: All participants successfully completed training without adverse events. Repetitions ranged from 5 to 60 (median 37), with Modified ...

TASCI—transcutaneous tibial nerve stimulation in patients ...

Tibial nerve stimulation applied acutely after spinal cord injury in rats had an immediate beneficial effect on lower urinary tract dysfunction; ...