This trialtests a non-invasive spinal cord stimulator to improve arm use & reduce stiffness in people with spinal cord injuries.
- Spinal Cord Injury
4 Primary · 7 Secondary · Reporting Duration: "Repeated measurements once every two weeks throughout the study, an average of 10 months".
2 Treatment Groups
1 of 2
1 of 2
9 Total Participants · 2 Treatment Groups
Primary Treatment: Open-loop Stimulation · No Placebo Group · N/A
Who is running the clinical trial?
Age 21 - 70 · All Participants · 7 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Inanici, Fatma, Soshi Samejima, Parag Gad, V. Reggie Edgerton, Christoph P. Hofstetter, and Chet T. Moritz. 2018. “Transcutaneous Electrical Spinal Stimulation Promotes Long-term Recovery of Upper Extremity Function in Chronic Tetraplegia”. IEEE Transactions on Neural Systems and Rehabilitation Engineering. Institute of Electrical and Electronics Engineers (IEEE). doi:10.1109/tnsre.2018.2834339.
- Inanici F, Brighton LN, Samejima S, Hofstetter CP, Moritz CT. Transcutaneous Spinal Cord Stimulation Restores Hand and Arm Function After Spinal Cord Injury. IEEE Trans Neural Syst Rehabil Eng. 2021;29:310-319. doi: 10.1109/TNSRE.2021.3049133. Epub 2021 Mar 2.
- McPherson JG, Miller RR, Perlmutter SI. Targeted, activity-dependent spinal stimulation produces long-lasting motor recovery in chronic cervical spinal cord injury. Proc Natl Acad Sci U S A. 2015 Sep 29;112(39):12193-8. doi: 10.1073/pnas.1505383112. Epub 2015 Sep 14.
- Chet Moritz 2022. "Closed-loop Spinal Stimulation for Restoration of Upper Extremity Function After Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05267951.
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 (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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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" - Anonymous Online Contributor
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." - Anonymous Online Contributor