Use of Point-of-care Neuro-sacral Electrophysiology Following Spinal Cord Injury

NCT06333886 | Active Not Recruiting

• 1 other identifier: ciusss-nordmtl_ESG
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

Assessing the sacral nerves is an integral aspect of the evaluation after a spinal cord injury. Being located at the lower end of the spinal cord, the sacral nerves reflect how signals travel through the injured spinal cord. Sacral assessment is therefore essential to determine the level and severity of the spinal cord injury, which helps selecting the proper treatment and predicting recovery (worse when abnormal sacral function. The current assessment relies solely on a manual evaluation, which depends heavily on the physician's experience and does not provide any quantitative value of the dysfunction. The lack of a quantitative method adapted to the clinical setting is a major barrier limiting our knowledge on the impact of sacral function on recovery. We have recently developed an electrophysiological method providing quantitative sacral assessment at bedside after spinal cord injuries. Using this method, we will quantify sacral function in 250 patients with acute spinal cord injuries, and determine its association with recovery 6 months post-injury. We hypothesize that sacral function assessed early within the first 6 weeks after the injury with our method is associated with a better 6-month recovery of motor, sensory, bowel and bladder function. Our objectives are to assess the changes is sacral function during the first 6 months after the injury, and the relationship between early sacral function and 6-month recovery. Sacral function and recovery will be assessed up to 6 months post-injury by the attending physician, in order to measure the electromyographic magnitude of voluntary anal contraction, electromyographic magnitude of anal contraction elicited through sacral reflex testing, and minimal electrical stimulation for which anal sensation is present. The analysis will determine if and how sacral function evolves in time, and if there are specific quantitative criteria of sacral function that physicians can use to determine if patient will have a favorable recovery.

Conditions

Spinal Cord Injuries; Neurogenic Bowel; Neurogenic Bladder Dysfunction

Keywords

Spinal cord injury; Electrophysiology; Neuro-sacral dysfunction; Neurogenic bowel and bladder

Outcome Measures

Primary Outcomes (1)

• Precise assessment and evaluation of neuro-sacral dysfunction

  Improve the precision and accuracy for identifying of neuro-sacral dysfunction and improve understanding of the early changes in neuro-sacral dysfunction, bringing new knowledge on the predictors of recovery. Identification of clinical phenotypes of neuro-sacral function and propose objective threshold values to help clinicians identifying proper care trajectory and optimize resources use, using an accessible and validated method that is well tolerated by patients.

  4 years

Secondary Outcomes (2)

• Assessment of clinical phenotypes

  4 years

• Clinical prognosis assessment

  4 years

Study Arms (1)

SCI patients with neuro-sacral dysfunction

450 patients with traumatic and non-traumatic acute SCI admitted to a level-1 trauma hospital in Montreal, Quebec, Canada

Device: Sacral electromyography

Interventions

Sacral electromyography DEVICE

Assessment of neuro-sacral function using point-of-care sacral surface electromyography

SCI patients with neuro-sacral dysfunction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute traumatic and atraumatic (tumoral) spinal cord injury patients admitted to a level-1 trauma centre in Montreal, Quebec, Canada requiring spinal surgery.

You may qualify if:

• Male or female aged \>/= 18 years
• Spinal cord injury (including cauda equina) due to trauma or extra-dural spinal tumour
• American Spinal Injury Association Impairment Scale grade A, B, C or D
• Neurological level of injury between C0 and S5
• Neurological examination performed prior to surgery according to the ISNCSCI\*
• Surgical treatment done at our institution within 5 days of onset of neurological symptoms
• Patient is willing and able to provide informed consent in English or French

You may not qualify if:

• Injury not due to blunt trauma or tumour
• Assessment of neuro-sacral function cannot be performed postoperatively within 1 week on the injury (e.g. due to cognitive or brain disorder, sedation, etc.)
• Expected survival less than 6 months
• No spinal surgery performed
• Subacute or chronic spinal cord or cauda equina injury at spinal surgery (delay \> 5 days between onset of neurological symptoms and surgery)
• Incomplete or aborted surgical decompression of spinal cord or cauda equina
• Complete spinal cord transection confirmed from preoperative MRI and/or during surgery
• Associated or preexisting anorectal or pelvic pathology
• Pre-existing neurological disorders such as cerebrovascular disease, Parkinson's disease, multiple sclerosis, stroke, etc.
• Limitation (e.g. in prision, living in another country, unwilling to comply with follow-up visits) to attend follow-up visits up to 6 months after the injury
• Major cognitive deficits precluding informed consent and/or assessments

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead

Study Sites (1)

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

Related Publications (16)

• Lim V, Mac-Thiong JM, Dionne A, Begin J, Richard-Denis A. Clinical Protocol for Identifying and Managing Bladder Dysfunction during Acute Care after Traumatic Spinal Cord Injury. J Neurotrauma. 2021 Mar 15;38(6):718-724. doi: 10.1089/neu.2020.7190. Epub 2020 Dec 3.

  PMID: 33121377 BACKGROUND

• Facchinello Y, Beausejour M, Richard-Denis A, Thompson C, Mac-Thiong JM. Use of Regression Tree Analysis for Predicting the Functional Outcome after Traumatic Spinal Cord Injury. J Neurotrauma. 2021 May 1;38(9):1285-1291. doi: 10.1089/neu.2017.5321.

  PMID: 29065782 BACKGROUND

• Kaminski L, Cordemans V, Cernat E, M'Bra KI, Mac-Thiong JM. Functional Outcome Prediction after Traumatic Spinal Cord Injury Based on Acute Clinical Factors. J Neurotrauma. 2017 Jun 15;34(12):2027-2033. doi: 10.1089/neu.2016.4955. Epub 2017 Mar 21.

  PMID: 28129730 BACKGROUND

• Denis AR, Feldman D, Thompson C, Mac-Thiong JM. Prediction of functional recovery six months following traumatic spinal cord injury during acute care hospitalization. J Spinal Cord Med. 2018 May;41(3):309-317. doi: 10.1080/10790268.2017.1279818. Epub 2017 Feb 15.

  PMID: 28198660 BACKGROUND

• Richard-Denis A, Chatta R, Thompson C, Mac-Thiong JM. Patterns and predictors of functional recovery from the subacute to the chronic phase following a traumatic spinal cord injury: a prospective study. Spinal Cord. 2020 Jan;58(1):43-52. doi: 10.1038/s41393-019-0341-x. Epub 2019 Aug 28.

  PMID: 31462758 BACKGROUND

• Richard-Denis A, Beausejour M, Thompson C, Nguyen BH, Mac-Thiong JM. Early Predictors of Global Functional Outcome after Traumatic Spinal Cord Injury: A Systematic Review. J Neurotrauma. 2018 Aug 1;35(15):1705-1725. doi: 10.1089/neu.2017.5403. Epub 2018 Apr 17.

  PMID: 29455634 BACKGROUND

• Greciet N, Mac-Thiong JM, Nguyen BH, Richard-Denis A. The Functional Impact of the Absence of a Bulbocavernosus Reflex in the Postoperative Period After a Motor-Complete Traumatic Spinal Cord Injury. Am J Phys Med Rehabil. 2020 Aug;99(8):712-718. doi: 10.1097/PHM.0000000000001398.

  PMID: 32032092 BACKGROUND

• Richard-Denis A, Thompson C, Mac-Thiong JM. Quality of life in the subacute period following a cervical traumatic spinal cord injury based on the initial severity of the injury: a prospective cohort study. Spinal Cord. 2018 Nov;56(11):1042-1050. doi: 10.1038/s41393-018-0178-8. Epub 2018 Jul 3.

  PMID: 29970920 BACKGROUND

• Richard-Denis A, Benazet D, Thompson C, Mac-Thiong JM. Determining priorities in functional rehabilitation related to quality of life one-year following a traumatic spinal cord injury. J Spinal Cord Med. 2020 Mar;43(2):241-246. doi: 10.1080/10790268.2018.1517138. Epub 2018 Sep 6.

  PMID: 30188803 BACKGROUND

• Goulet J, Richard-Denis A, Thompson C, Mac-Thiong JM. Relationships Between Specific Functional Abilities and Health-Related Quality of Life in Chronic Traumatic Spinal Cord Injury. Am J Phys Med Rehabil. 2019 Jan;98(1):14-19. doi: 10.1097/PHM.0000000000001006.

  PMID: 30157080 BACKGROUND

• Simpson LA, Eng JJ, Hsieh JT, Wolfe DL; Spinal Cord Injury Rehabilitation Evidence Scire Research Team. The health and life priorities of individuals with spinal cord injury: a systematic review. J Neurotrauma. 2012 May 20;29(8):1548-55. doi: 10.1089/neu.2011.2226. Epub 2012 Apr 18.

  PMID: 22320160 BACKGROUND

• Hagen EM. Acute complications of spinal cord injuries. World J Orthop. 2015 Jan 18;6(1):17-23. doi: 10.5312/wjo.v6.i1.17. eCollection 2015 Jan 18.

  PMID: 25621207 BACKGROUND

• Fawcett JW, Curt A, Steeves JD, Coleman WP, Tuszynski MH, Lammertse D, Bartlett PF, Blight AR, Dietz V, Ditunno J, Dobkin BH, Havton LA, Ellaway PH, Fehlings MG, Privat A, Grossman R, Guest JD, Kleitman N, Nakamura M, Gaviria M, Short D. Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: spontaneous recovery after spinal cord injury and statistical power needed for therapeutic clinical trials. Spinal Cord. 2007 Mar;45(3):190-205. doi: 10.1038/sj.sc.3102007. Epub 2006 Dec 19.

  PMID: 17179973 BACKGROUND

• Kurze I, Geng V, Bothig R. Guideline for the management of neurogenic bowel dysfunction in spinal cord injury/disease. Spinal Cord. 2022 May;60(5):435-443. doi: 10.1038/s41393-022-00786-x. Epub 2022 Mar 25.

  PMID: 35332274 BACKGROUND

• Johns J, Krogh K, Rodriguez GM, Eng J, Haller E, Heinen M, Laredo R, Longo W, Montero-Colon W, Wilson C, Korsten M. Management of Neurogenic Bowel Dysfunction in Adults after Spinal Cord Injury: Clinical Practice Guideline for Health Care Providers. Top Spinal Cord Inj Rehabil. 2021 Spring;27(2):75-151. doi: 10.46292/sci2702-75. Epub 2021 May 24. No abstract available.

  PMID: 34108835 BACKGROUND

• Gardner A, Gardner E, Morley T. Cauda equina syndrome: a review of the current clinical and medico-legal position. Eur Spine J. 2011 May;20(5):690-7. doi: 10.1007/s00586-010-1668-3. Epub 2010 Dec 31.

  PMID: 21193933 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Neurogenic Bowel

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Department of Medicine, Université de Montréal; Physiatrist, Hôpital du Sacré-Coeur de Montréal; Researcher, CIUSSS du Nord-de-l'Île

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: March 18, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)