Bulbocavernosus ReflexNCT04316195
Evaluation of the Bulbocavernosus Reflex After Acute Spinal Cord Injury
An observational study of Bulbocavernosus Reflex and Spinal Cord Injuries, run by Andréane Richard-Denis at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the possibility to use electromyography in acute phase after a traumatic spinal cord injury to measure quantitatively and objectively the bulbocavernosus reflex. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bulbocavernosus Reflex, Spinal Cord Injuries
- What is being tested?
- Assessment of the bulbocavernosus reflex
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2020to 31 Aug 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient admitted to the Hôpital du Sacré-Coeur de Montréal for a traumatic spinal injury.
Who may be able to join
- male or female age of 18 years or older
- patient with fracture, fracture-dislocation or vertebral dislocation from C0 to T12 inclusively
- patient with neurological impairment involving the motor spinal cord (severity AIS grade A or B) on initial assessment
- patient admitted to Hôpital du Sacré-Coeur de Montréal within 72 hours for trauma
- patient transfer to intensive functional rehabilitation
Who cannot join
- pregnancy
- suspicion of sacral nerve damage (caused by trauma or other co-morbidities)
- spinal cord syndrome (caused by trauma or other comorbidities) or spinal cord signal abnormality on magnetic resonance imaging
- pre-existing major neurological impairment (e.g. stroke, Parkinson's disease, etc.)
- inability to consent (coma, delirium, etc.)
- perineal injury preventing the sacral EMG procedure
Trial locations and contacts
1 site in 1 country.
Canada1 site
CIUSSS du Nord-de-l'île-de-Montréal-Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, H4J 1C5
About this study
Official title: Electromyographic Evaluation of the Bulbocavernosus Reflex After Acute Spinal Cord Injury: a New Prognostic Concept
The purpose of this study is to evaluate the possibility to use electromyography in acute phase after a traumatic spinal cord injury to measure quantitatively and objectively the bulbocavernosus reflex. This study also aims to determine if there is a relationship between the bulbocavernosus reflex and neuro-functional recovery 3 months after a traumatic spinal cord injury. To do so, 20 patients admitted for acute traumatic spinal cord injury will be recruited prospectively. Within 72 hours post-trauma, the bulbocavernous reflex of all participants will be assessed according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) and by electromyography. Neurological improvement during the rehabilitation process and functional status at 3 months following the traumatic spinal cord injury will also be assessed.
Read the detailed description
Traumatic spinal cord injuries cause severe neurological deficits (motor, sensory and autonomic disorders). Affected individuals have functional limitations and a reduced quality of life that result in high medical and social costs. Some studies have shown that early rehabilitation improves recovery. It seems therefore essential to optimize patient management in the acute phase in order to improve interventions and optimize their functional recovery.
A major barrier to early patient management is associated with a lack of knowledge about the neurophysiological mechanisms of acute spinal cord injury. Moreover, early assessment of prognosis is still difficult to make. The early assessment is based almost exclusively on the clinical neurological examination and does not include an objective measurement of underlying neurophysiological processes. The possibility to establish an accurate neuro-functional prognosis at an early stage will have the advantage to guide clinical decision, allow the development of an appropriate rehabilitation plan and figure out the long-term needs of the patient while promoting better collaboration.
Clinical neurological examination includes among other things, the evaluation of the bulbocavernosus reflex. The purpose of this study is to evaluate the possibility to use electromyography in acute phase after a traumatic spinal cord injury to measure quantitatively and objectively the bulbocavernosus reflex. This study also aims to determine if there is a relationship between the bulbocavernous reflex and neuro-functional recovery 3 months after a traumatic spinal cord injury.
The bulbocavernous reflex of patients admitted for acute traumatic spinal cord injury will be assessed within 72 hours post-trauma according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) and by electromyography. Neurological improvement during the rehabilitation process and functional status at 3 months following the traumatic spinal cord injury will also be assessed. Descriptive analyses will be proposed to characterize the bulbocavernous reflex obtained by electromyography evaluation. Comparative analyses will be carried out to describe the characteristics of patients with different bulbocavernosus reflex stimulation thresholds. Correlations will also be established to determine the relationship between the electromyography evaluation of the bulbocavernosus reflex and the neurological and functional improvement of the patient.
- Conditions
- Bulbocavernosus Reflex, Spinal Cord Injuries
- Being tested
- Assessment of the bulbocavernosus reflex
- Keywords
- Bulbocavernosus reflex following a traumatic spinal cord injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of the bulbocavernosus reflexDiagnostic test
According to the International Standards for Neurological Classification of Spinal Cord : The standard examination consists of the contraction of the bulbocavernous muscle following stimulation of the glans of the penis in men and of the clitoris in women.
By electromyography: The electromyography consists to stimulate the bulbocavernosus reflex with a bipolar probe apply on the glans for men, and on the clitoris in women. A surface electrode will be positioned on the right or left bulbocavernous muscle at the base of the penis (or vagina) and the anus for recording. The bulbocavernous reflex will be obtained by stimulation at a frequency of 1.5Hz and an amplitude of 14 to 47 mA.
| Study group | Role | What they receive |
|---|---|---|
| Patient admitted for an acute traumatic spinal cord injury | Not described Receives: Diagnostic Test: Assessment of the bulbocavernosus reflex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the bulbocavernosus reflex using electromyographic assessment within 72 hours of a traumatic spinal cord injury
Determine stimulation threshold, latency and amplitude of the signal
Measured: During the acute care hospitalization, max 72 hours
Determine the relationship between the bulbocavernosus reflex and the neurological and functional recovery of patients 3 months after a traumatic spinal cord injury
Related neurological and functional improvement according to acute electromyographic reflex measurement
Measured: After hospitalization, 3 months post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start1 Aug 2020 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Bulbocavernosus ReflexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Andréane Richard-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andréane Richard-Denis, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Investigators
- Andréane Richard-Denis, M.D., MSC., Principal investigator, CIUSSS du Nord-de-l'Île-de-Montréal-Hôpital du Sacré-Cœur de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316195
- Sponsor's protocol ID
- 2019-1709
- Status last verified
- Mar 2020
- First submitted
- 18 Mar 2020
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29455634Simpson 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.
PubMed 22320160Richard-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.
PubMed 29970920Krueger H, Noonan VK, Trenaman LM, Joshi P, Rivers CS. The economic burden of traumatic spinal cord injury in Canada. Chronic Dis Inj Can. 2013 Jun;33(3):113-22. English, French.
PubMed 23735450Hachem LD, Ahuja CS, Fehlings MG. Assessment and management of acute spinal cord injury: From point of injury to rehabilitation. J Spinal Cord Med. 2017 Nov;40(6):665-675. doi: 10.1080/10790268.2017.1329076. Epub 2017 Jun 1.
PubMed 28571527Dvorak MF, Noonan VK, Fallah N, Fisher CG, Rivers CS, Ahn H, Tsai EC, Linassi AG, Christie SD, Attabib N, Hurlbert RJ, Fourney DR, Johnson MG, Fehlings MG, Drew B, Bailey CS, Paquet J, Parent S, Townson A, Ho C, Craven BC, Gagnon D, Tsui D, Fox R, Mac-Thiong JM, Kwon BK. Minimizing errors in acute traumatic spinal cord injury trials by acknowledging the heterogeneity of spinal cord anatomy and injury severity: an observational Canadian cohort analysis. J Neurotrauma. 2014 Sep 15;31(18):1540-7. doi: 10.1089/neu.2013.3278. Epub 2014 Jul 8.
PubMed 24811484Kirshblum SC, Burns SP, Biering-Sorensen F, Donovan W, Graves DE, Jha A, Johansen M, Jones L, Krassioukov A, Mulcahey MJ, Schmidt-Read M, Waring W. International standards for neurological classification of spinal cord injury (revised 2011). J Spinal Cord Med. 2011 Nov;34(6):535-46. doi: 10.1179/204577211X13207446293695. No abstract available.
PubMed 22330108Consortium for Spinal Cord Medicine. Early acute management in adults with spinal cord injury: a clinical practice guideline for health-care professionals. J Spinal Cord Med. 2008;31(4):403-79. doi: 10.1043/1079-0268-31.4.408. No abstract available.
PubMed 18959359Podnar S. Neurophysiologic studies of the penilo-cavernosus reflex: normative data. Neurourol Urodyn. 2007;26(6):864-9. doi: 10.1002/nau.20411.
PubMed 17335052Granata G, Padua L, Rossi F, De Franco P, Coraci D, Rossi V. Electrophysiological study of the bulbocavernosus reflex: normative data. Funct Neurol. 2013 Oct-Dec;28(4):293-5.
PubMed 24598398Fehlings MG, Tetreault LA, Aarabi B, Anderson P, Arnold PM, Brodke DS, Chiba K, Dettori JR, Furlan JC, Harrop JS, Hawryluk G, Holly LT, Howley S, Jeji T, Kalsi-Ryan S, Kotter M, Kurpad S, Kwon BK, Marino RJ, Martin AR, Massicotte E, Merli G, Middleton JW, Nakashima H, Nagoshi N, Palmieri K, Singh A, Skelly AC, Tsai EC, Vaccaro A, Wilson JR, Yee A, Burns AS. A Clinical Practice Guideline for the Management of Patients With Acute Spinal Cord Injury: Recommendations on the Type and Timing of Rehabilitation. Global Spine J. 2017 Sep;7(3 Suppl):231S-238S. doi: 10.1177/2192568217701910. Epub 2017 Sep 5.
PubMed 29164029
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyographic Evaluation of the Bulbocavernosus Reflex After Acute Spinal Cord Injury: a New Prognostic Concept
- ClinicalTrials.gov ID
- NCT04316195
- Acronym / sponsor ID
- 2019-1709
- Conditions
- Bulbocavernosus Reflex, Spinal Cord Injuries
- Keywords
- Bulbocavernosus reflex following a traumatic spinal cord injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Andréane Richard-DenisUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the possibility to use electromyography in acute phase after a traumatic spinal cord injury to measure quantitatively and objectively the bulbocavernosus reflex. This study also aims to determine if there is a relationship between the bulbocavernosus reflex and neuro-functional recovery 3 months after a traumatic spinal cord injury. To do so, 20 patients admitted for acute traumatic spinal cord injury will be recruited prospectively. Within 72 hours post-trauma, the bulbocavernous reflex of all participants will be assessed according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) and by electromyography. Neurological improvement during the rehabilitation process and functional status at 3 months following the traumatic spinal cord injury will also be assessed.
Detailed description
Traumatic spinal cord injuries cause severe neurological deficits (motor, sensory and autonomic disorders). Affected individuals have functional limitations and a reduced quality of life that result in high medical and social costs. Some studies have shown that early rehabilitation improves recovery. It seems therefore essential to optimize patient management in the acute phase in order to improve interventions and optimize their functional recovery.
A major barrier to early patient management is associated with a lack of knowledge about the neurophysiological mechanisms of acute spinal cord injury. Moreover, early assessment of prognosis is still difficult to make. The early assessment is based almost exclusively on the clinical neurological examination and does not include an objective measurement of underlying neurophysiological processes. The possibility to establish an accurate neuro-functional prognosis at an early stage will have the advantage to guide clinical decision, allow the development of an appropriate rehabilitation plan and figure out the long-term needs of the patient while promoting better collaboration.
Clinical neurological examination includes among other things, the evaluation of the bulbocavernosus reflex. The purpose of this study is to evaluate the possibility to use electromyography in acute phase after a traumatic spinal cord injury to measure quantitatively and objectively the bulbocavernosus reflex. This study also aims to determine if there is a relationship between the bulbocavernous reflex and neuro-functional recovery 3 months after a traumatic spinal cord injury.
The bulbocavernous reflex of patients admitted for acute traumatic spinal cord injury will be assessed within 72 hours post-trauma according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) and by electromyography. Neurological improvement during the rehabilitation process and functional status at 3 months following the traumatic spinal cord injury will also be assessed. Descriptive analyses will be proposed to characterize the bulbocavernous reflex obtained by electromyography evaluation. Comparative analyses will be carried out to describe the characteristics of patients with different bulbocavernosus reflex stimulation thresholds. Correlations will also be established to determine the relationship between the electromyography evaluation of the bulbocavernosus reflex and the neurological and functional improvement of the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient admitted for an acute traumatic spinal cord injury | – | Diagnostic Test: Assessment of the bulbocavernosus reflex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted to the Hôpital du Sacré-Coeur de Montréal for a traumatic spinal injury.
Key inclusion criteria (5 listed)
- male or female age of 18 years or older
- patient with fracture, fracture-dislocation or vertebral dislocation from C0 to T12 inclusively
- patient with neurological impairment involving the motor spinal cord (severity AIS grade A or B) on initial assessment
- patient admitted to Hôpital du Sacré-Coeur de Montréal within 72 hours for trauma
- patient transfer to intensive functional rehabilitation
Key exclusion criteria (6 listed)
- pregnancy
- suspicion of sacral nerve damage (caused by trauma or other co-morbidities)
- spinal cord syndrome (caused by trauma or other comorbidities) or spinal cord signal abnormality on magnetic resonance imaging
- pre-existing major neurological impairment (e.g. stroke, Parkinson's disease, etc.)
- inability to consent (coma, delirium, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of the bulbocavernosus reflexAccording to the International Standards for Neurological Classification of Spinal Cord : The standard examination consists of the contraction of the bulbocavernous muscle following stimulation of the glans of the penis in men and of the clitoris in women. By electromyography: The electromyography consists to stimulate the bulbocavernosus reflex with a bipolar probe apply on the glans for men, and on the clitoris in women. A surface electrode will be positioned on the right or left bulbocavernous muscle at the base of the penis (or vagina) and the anus for recording. The bulbocavernous reflex will be obtained by stimulation at a frequency of 1.5Hz and an amplitude of 14 to 47 mA. | Diagnostic test | Patient admitted for an acute traumatic spinal cord injury |
Primary outcome
Characterize the bulbocavernosus reflex using electromyographic assessment within 72 hours of a traumatic spinal cord injury
Time frame: During the acute care hospitalization, max 72 hours
Determine stimulation threshold, latency and amplitude of the signal
Determine the relationship between the bulbocavernosus reflex and the neurological and functional recovery of patients 3 months after a traumatic spinal cord injury
Time frame: After hospitalization, 3 months post operation
Related neurological and functional improvement according to acute electromyographic reflex measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Background: PubMed 29455634Richard-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.
- Background: PubMed 22320160Simpson 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.
- Background: PubMed 29970920Richard-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.
- Background: PubMed 23735450Krueger H, Noonan VK, Trenaman LM, Joshi P, Rivers CS. The economic burden of traumatic spinal cord injury in Canada. Chronic Dis Inj Can. 2013 Jun;33(3):113-22. English, French.
- Background: PubMed 28571527Hachem LD, Ahuja CS, Fehlings MG. Assessment and management of acute spinal cord injury: From point of injury to rehabilitation. J Spinal Cord Med. 2017 Nov;40(6):665-675. doi: 10.1080/10790268.2017.1329076. Epub 2017 Jun 1.
- Background: PubMed 24811484Dvorak MF, Noonan VK, Fallah N, Fisher CG, Rivers CS, Ahn H, Tsai EC, Linassi AG, Christie SD, Attabib N, Hurlbert RJ, Fourney DR, Johnson MG, Fehlings MG, Drew B, Bailey CS, Paquet J, Parent S, Townson A, Ho C, Craven BC, Gagnon D, Tsui D, Fox R, Mac-Thiong JM, Kwon BK. Minimizing errors in acute traumatic spinal cord injury trials by acknowledging the heterogeneity of spinal cord anatomy and injury severity: an observational Canadian cohort analysis. J Neurotrauma. 2014 Sep 15;31(18):1540-7. doi: 10.1089/neu.2013.3278. Epub 2014 Jul 8.
- Background: PubMed 22330108Kirshblum SC, Burns SP, Biering-Sorensen F, Donovan W, Graves DE, Jha A, Johansen M, Jones L, Krassioukov A, Mulcahey MJ, Schmidt-Read M, Waring W. International standards for neurological classification of spinal cord injury (revised 2011). J Spinal Cord Med. 2011 Nov;34(6):535-46. doi: 10.1179/204577211X13207446293695. No abstract available.
- Background: PubMed 18959359Consortium for Spinal Cord Medicine. Early acute management in adults with spinal cord injury: a clinical practice guideline for health-care professionals. J Spinal Cord Med. 2008;31(4):403-79. doi: 10.1043/1079-0268-31.4.408. No abstract available.
- Background: PubMed 17335052Podnar S. Neurophysiologic studies of the penilo-cavernosus reflex: normative data. Neurourol Urodyn. 2007;26(6):864-9. doi: 10.1002/nau.20411.
- Background: PubMed 24598398Granata G, Padua L, Rossi F, De Franco P, Coraci D, Rossi V. Electrophysiological study of the bulbocavernosus reflex: normative data. Funct Neurol. 2013 Oct-Dec;28(4):293-5.
- Background: PubMed 29164029Fehlings MG, Tetreault LA, Aarabi B, Anderson P, Arnold PM, Brodke DS, Chiba K, Dettori JR, Furlan JC, Harrop JS, Hawryluk G, Holly LT, Howley S, Jeji T, Kalsi-Ryan S, Kotter M, Kurpad S, Kwon BK, Marino RJ, Martin AR, Massicotte E, Merli G, Middleton JW, Nakashima H, Nagoshi N, Palmieri K, Singh A, Skelly AC, Tsai EC, Vaccaro A, Wilson JR, Yee A, Burns AS. A Clinical Practice Guideline for the Management of Patients With Acute Spinal Cord Injury: Recommendations on the Type and Timing of Rehabilitation. Global Spine J. 2017 Sep;7(3 Suppl):231S-238S. doi: 10.1177/2192568217701910. Epub 2017 Sep 5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andréane Richard-Denis, M.D., MSC. principal investigator
CIUSSS du Nord-de-l'Île-de-Montréal-Hôpital du Sacré-Cœur de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bulbocavernosus Reflex and Spinal Cord Injuries, run by Andréane Richard-Denis at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the bulbocavernosus reflex using electromyographic assessment within 72 hours of a traumatic spinal cord injury (time frame: During the acute care hospitalization, max 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04316195, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.