Utilizing Neuromodulation in the Treatment of Spinal Cord Injury: An Assessment of Clinical Trials from the National ClinicalTrials.gov Database

Mickey E Abraham; Moshe Shalom; Julian Gendreau; Justin Gold; Garret Pierzchajlo; Noah Pierzchajlo; Sachiv Chakravarti; Ronald Sahyouni; Nikhil Murthy; Joseph Ciacci

doi:10.1016/j.wneu.2023.06.050

Utilizing Neuromodulation in the Treatment of Spinal Cord Injury: An Assessment of Clinical Trials from the National ClinicalTrials.gov Database

World Neurosurg. 2023 Jun 21:S1878-8750(23)00818-5. doi: 10.1016/j.wneu.2023.06.050. Online ahead of print.

Authors

Affiliations

¹ Department of Neurosurgery, University of California San Diego, La Jolla, California, USA. Electronic address: mabraham@ucsd.edu.
² Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
³ Department of Biomedical Engineering, Johns Hopkins Whiting School of Engineering, Baltimore, Maryland, USA.
⁴ Cooper Medical School, Camden, New Jersey, USA.
⁵ Mercer University School of Medicine, Savannah, Georgia, USA.
⁶ Krieger School of Arts and Sciences, Johns Hopkins University, Baltimore, Maryland, USA.
⁷ Department of Neurosurgery, University of California San Diego, La Jolla, California, USA.

PMID: 37352921
DOI: 10.1016/j.wneu.2023.06.050

Abstract

Objective: Spinal cord injury (SCI) is responsible for approximately 18,000 trauma cases each year in the United States, often resulting in debilitating motor and autonomic disability. Neuromodulation is a rapidly growing field of interest in the neurosurgical field and has additionally shown promise in the treatment of SCI. This review characterizes all clinical trials to date studying neuromodulation for the treatment of SCI.

Methods: The ClinicalTrials.gov database was queried using the search terms "neuromodulation" and "spinal cord injury" on ClinicalTrials.gov. Trials were excluded if they were not yet recruiting, suspended, terminated early, or of unknown status.

Results: In total, 33 clinical trials were included in this study. 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 (42.4%) utilized transcutaneous spinal stimulation, 7 (21.2%) utilized epidural electrical stimulation, and 6 (18.2%) utilized tibial nerve stimulation. There was an uptrend of clinical trials studying SCI indexed on PubMed, which was comparable to the increased number of publications indexed overall (Pearson correlation, P < 0.001). Of these, only 1 study regarding home tibial nerve stimulation for neurogenic bladder had published data, which was performed with no adverse events.

Conclusions: Neuromodulation in SCI studies currently assess transcutaneous spinal stimulation, epidural electrical stimulation, and tibial nerve stimulation. There is currently 1 completed study suggesting feasibility of home neuromodulation techniques without adverse events. The results of trials that will be completed in the next few years will help dictate the potential of neuromodulation as a treatment for SCI.

Keywords: Clinical trials; Epidural spinal stimulation; Neuromodulation; Peripheral nerve stimulation; Spinal cord injury; Transcutaneous spinal stimulation.