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Spinal Cord Stimulation for Spinal Cord Injury
Study Summary
This trialtests a non-invasive spinal cord stimulator to improve arm use & reduce stiffness in people with spinal cord injuries.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I struggle with daily tasks like dressing or feeding due to hand issues.I have nerve damage in my hands or feet.I do not have any unhealed injuries or frequent infections that could affect my arm rehabilitation.My heart and lung health allows me to do arm exercises.I am currently taking tizanidine, dantrolene, or diazepam.I can perform simple tasks when guided.I have had botulinum toxin injections in my arm muscles within the last 6 months.I have had surgery to move tendons or nerves in my arm or hand.I understand and can safely follow the study's procedures.I rely on a machine to help me breathe.You have metal devices and implants in your head, such as deep brain stimulators, aneurysm clips, stents, or vagus nerve stimulators.I have a history of chronic headaches or migraines.I have cancer.I have a rheumatic disease like rheumatoid arthritis or lupus.I have a heart or muscle condition that stops me from fully joining in physical therapy.I have a spinal cord injury above my shoulders and still have some movement or sensation below the injury.I have or had syringomyelia with symptoms like pain, weakness, sensory loss, or issues with bowel/bladder.I do not have uncontrolled high blood pressure or serious heart, lung, or blood clotting issues.I have a history of neurological diseases like stroke or MS.My spinal cord injury is due to an autoimmune disease.You have had a very serious allergic reaction that could not be treated with antihistamines.You have a device like a pacemaker, cochlear implant, or baclofen pump implanted in your body.I have a history of seizures or am at high risk for seizures.I can attend training and assessment sessions 3 times a week.I have enough support to attend all required sessions for 40 weeks.
- Group 1: Open-loop Stimulation
- Group 2: Close-loop Stimulation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What specific objectives are researchers attempting to attain with this clinical trial?
"The principal benchmark that needs to be observed over the course of 10 months is Change from baseline- Graded Redefined Assessment of Strength, Sensation, and Prehension version 2. Other secondary objectives comprise Change from baseline- International Standards of Autonomic Functions after [Spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury) (Clinician assessment), Change from baseline- International Standards for Neurologic Classification of Spinal Cord Injury - Motor Score (Standard manual muscle strength examination) and Change from baseline- Somatosensory Evoked Potentials (Electrophysiologic evaluation). The evaluations will take place biweekly throughout the trial period."
To what extent is this examination engaging people?
"Affirmative. Clinicaltrials.gov contains information that this experiment is actively recruiting participants and began recruitment on October 12th 2022, with the latest update being recorded a day later. The study requires 9 people from 1 facility to participate."
Does this trial continue to recruit participants?
"Affirmative. On clinicaltrials.gov, it is denoted that this medical trial was initially posted on December 10th 2022 and most recently updated on the 13th of that same month. Nine patients are required to be recruited at one centre for the study's completion."
Am I eligible to join the trial for this research project?
"This clinical trial requires the participation of 9 individuals between 21 and 70 years old who have suffered from a traumatic spinal cord injury. Additionally, these participants must possess C8 or higher cervical injuries (as classified by American Spinal Cord Injury Impairment Scale - C or D) that occurred at least one year ago; be able to complete simple motor tasks; read and speak English fluently; possess adequate social support for 40 weeks worth of sessions 3 times per week; not suffer from any cardiopulmonary disease nor autonomic dysreflexia which could limit their ability to actively participate in upper extremity rehabilitation activities or tests related to activities"
Is this experiment open to participants of a more advanced age?
"This trial requires participants to be at least 21 years old and no more than 70."
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