Spasticity, MuscleNCT04022187
Assessment of the Excitability of Spinal Motoneurons Using Stimulus-response Curves of the Bulbocavernosus Reflex
An observational study of Spasticity, Muscle, run by Pierre and Marie Curie University at 1 site in France.
Trial summary
Spasticity is commonly observed in neurological conditions such as Multiple Sclerosis and spinal cord injury. "Peripheral" spasticity, concerning in particular the striated muscles of the limbs is nowadays well known and studied with clinical scales (Ashworth, Taridieu...) or even electrophysiological methods… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Spasticity, Muscle
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jul 2019to 30 Sep 2019
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who will be referred to our specialized neuro-urology service for electrophysiological and urodynamic explorations
Who may be able to join
- 18 years old minimum
- Subjects with spinal cord injury or multiple sclerosis, requiring an electrophysiological and urodynamic explorations in our neuro-urology specialized department, with a strictly supra-sacral central neurological condition.
- Subjects with stress urinary incontinence (SUI) requiring perineal explorations including a cystometry and a perineal EMG.
Who cannot join
- Subjects with peripheral neurological impairment (cauda equina syndrome, medullary cone syndrome, advanced diabetes)
- Subjects who received a treatment by injection of intra-detrusorian botulinum toxin in the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Spasticity is commonly observed in neurological conditions such as Multiple Sclerosis and spinal cord injury. "Peripheral" spasticity, concerning in particular the striated muscles of the limbs is nowadays well known and studied with clinical scales (Ashworth, Taridieu...) or even electrophysiological methods (H-reflex, T-reflex...). However, this spasticity can also affect the perineal muscles and more generally the pelvic muscles. However, there is to date no validated and standardized method for evaluating this pelvi-perineal spasticity.
The aim of the study will be to assess the spinal motoneurons excitability by using the stimulus-response curves of the bulbocavernosus reflex.
Read the detailed description
Spasticity defined by Lance in 1980 is "a motor disorder characterized by a velocity dependent increase in the tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflexes as one component of the upper motor neuron syndrome". The occurrence of spasticity, which is common in neurology when the pyramidal tract is affected, is commonly observed in the "peripheral" striated muscles. However, spasticity also concerns the perineal musculature, with "the exaggeration of the stretching reflex of the muscles accessible to pelvic touches". Although there are measurement scales commonly used in clinical practice, such as the Ashworth and Tardieu scales, or electrophysiological instrumental techniques (H reflex , T reflex), there is actually no objective and standardized measurement technique for pelvic spasticity. An interesting tool could be the bulbocavernosus reflex (BCR) which is a polysynaptic reflex with sacral integration. In addition to its diagnostic and topographical value due to its sacral integration, BCR could testify, by its modulation, to the control of the alpha motor neuron pool. It could therefore allow to assess motoneuronal excitability, whose increase may lead in central patients with supra-connal lesions (spinal cord injuries (SCI), multiple sclerosis (MS)), to a release of sacral automatism with exacerbation of reflex responses whether bladder (detrusor overactivity), sphincter (detrusor-sphincter dysynergia) or rectal (rectal overactivity).
The aim of the study will be to assess the sacral spinal motor neuron excitability using the stimulus-response curves of the BCR.
The investigators will conduct a prospective monocentric observational study in a specialized neuro-urology department. The main objective of this study will be to evaluate the spinal motoneuron excitability according to the degree of bladder repletion by modelling recruitment slopes (stimulus-response curves) of the BCR.
First of all, the investigators will assess the feasibility of conducting an analysis of BCR stimulus-response curves during a perineal electrophysiological exploration performed in a diagnostic context in patients referred for urinary, anorectal or genito-sexual disorders. BCR will be recorded after electrical stimulation of the dorsal nerve of the penis or the dorsal nerve of the clitoris, using a concentric needle electrode inserted into the left and then right bulbcavernous muscle. Stimulations will be performed at progressively increasing intensities and each response will be recorded. Acquisition will be performed using a Dantec™ Keypoint® G4 EMG device, Natus®. The initial stimulation intensity will be at the motor threshold, i.e. the degree of stimulation that determines a stable latent motor response and will then be increased by 10 to 10 mA to obtain the following 4 reflex responses. Once the acquisition will be completed, the curves will be analyzed allowing the analysis of the area under the curve (AUC) and the construction of the stimulus-response curves.
In a second step, the investigators will evaluate the possibility of modelling these stimulus-response curves after EMG recording using pre-gelled disposable surface electrodes placed on the external anal sphincter (EAS) during a cystometry performed in patients consulting for urinary disorders. The stimulation technique will be identical as described previously. Finally, the modulation of spinal motoneurons excitability according to the degree of bladder filling will be assessed by modelling the BCR stimulus-response curves, before and during a cystometry.
- Conditions
- Spasticity, Muscle
- Being tested
- Observational study : no intervention
- Keywords
- Bulbocavernosus reflex, Spasticity assessment, Motoneurone excitability, Stimulus-response curves
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study : no interventionOther
Observational study : no intervention, only exporting data
| Study group | Role | What they receive |
|---|---|---|
| Bulbocavernosus reflex assessment | Patients over 18 years old, consulting in neuro-urology department for urinary, anorectal or genito-sexual disorders. Receives: Other: Observational study : no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the recruitment slope according to the degree of bladder repletion
For each patient, an assessment of spinal motoneuron excitability by using the area under the motor response curve of the bulbocavernous reflex will be performed before starting the cystometry (empty bladder) and during urgent urination needs (also during the cystometry) to determine an alpha angle of the recruitment curve. The primary outcome is the variation in this alpha coefficient.
Measured: 1 day
Secondary outcomes (2)
Comparison of the variation of recruitment slope according to the bladder repletion : (empty bladder - B1) versus (B1-B3) variation
Measured: 1 day
Influence of neurological disease on spinal motoneuron excitability
comparison of the variation of the recruitment slope observed in neurological subjects versus non-neurological subjects.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start11 Jul 2019
- Primary completion11 Jul 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity, MuscleStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre and Marie Curie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gérard Amarenco, Pierre and Marie Curie University
- Investigators
- Gérard Amarenco, PHD, Principal investigator, Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022187
- Sponsor's protocol ID
- PGRC 001 GREEN
- Status last verified
- Feb 2022
- First submitted
- 13 Jul 2019
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Excitability of Spinal Motoneurons Using Stimulus-response Curves of the Bulbocavernosus Reflex
- ClinicalTrials.gov ID
- NCT04022187
- Acronym / sponsor ID
- PGRC 001 GREEN
- Conditions
- Spasticity, Muscle
- Keywords
- Bulbocavernosus reflex, Spasticity assessment, Motoneurone excitability, Stimulus-response curves
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pierre and Marie Curie UniversityUniversity, hospital or other
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 17 Jul 2019 (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.
Spasticity is commonly observed in neurological conditions such as Multiple Sclerosis and spinal cord injury. "Peripheral" spasticity, concerning in particular the striated muscles of the limbs is nowadays well known and studied with clinical scales (Ashworth, Taridieu...) or even electrophysiological methods (H-reflex, T-reflex...). However, this spasticity can also affect the perineal muscles and more generally the pelvic muscles. However, there is to date no validated and standardized method for evaluating this pelvi-perineal spasticity.
The aim of the study will be to assess the spinal motoneurons excitability by using the stimulus-response curves of the bulbocavernosus reflex.
Detailed description
Spasticity defined by Lance in 1980 is "a motor disorder characterized by a velocity dependent increase in the tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflexes as one component of the upper motor neuron syndrome". The occurrence of spasticity, which is common in neurology when the pyramidal tract is affected, is commonly observed in the "peripheral" striated muscles. However, spasticity also concerns the perineal musculature, with "the exaggeration of the stretching reflex of the muscles accessible to pelvic touches". Although there are measurement scales commonly used in clinical practice, such as the Ashworth and Tardieu scales, or electrophysiological instrumental techniques (H reflex , T reflex), there is actually no objective and standardized measurement technique for pelvic spasticity. An interesting tool could be the bulbocavernosus reflex (BCR) which is a polysynaptic reflex with sacral integration. In addition to its diagnostic and topographical value due to its sacral integration, BCR could testify, by its modulation, to the control of the alpha motor neuron pool. It could therefore allow to assess motoneuronal excitability, whose increase may lead in central patients with supra-connal lesions (spinal cord injuries (SCI), multiple sclerosis (MS)), to a release of sacral automatism with exacerbation of reflex responses whether bladder (detrusor overactivity), sphincter (detrusor-sphincter dysynergia) or rectal (rectal overactivity).
The aim of the study will be to assess the sacral spinal motor neuron excitability using the stimulus-response curves of the BCR.
The investigators will conduct a prospective monocentric observational study in a specialized neuro-urology department. The main objective of this study will be to evaluate the spinal motoneuron excitability according to the degree of bladder repletion by modelling recruitment slopes (stimulus-response curves) of the BCR.
First of all, the investigators will assess the feasibility of conducting an analysis of BCR stimulus-response curves during a perineal electrophysiological exploration performed in a diagnostic context in patients referred for urinary, anorectal or genito-sexual disorders. BCR will be recorded after electrical stimulation of the dorsal nerve of the penis or the dorsal nerve of the clitoris, using a concentric needle electrode inserted into the left and then right bulbcavernous muscle. Stimulations will be performed at progressively increasing intensities and each response will be recorded. Acquisition will be performed using a Dantec™ Keypoint® G4 EMG device, Natus®. The initial stimulation intensity will be at the motor threshold, i.e. the degree of stimulation that determines a stable latent motor response and will then be increased by 10 to 10 mA to obtain the following 4 reflex responses. Once the acquisition will be completed, the curves will be analyzed allowing the analysis of the area under the curve (AUC) and the construction of the stimulus-response curves.
In a second step, the investigators will evaluate the possibility of modelling these stimulus-response curves after EMG recording using pre-gelled disposable surface electrodes placed on the external anal sphincter (EAS) during a cystometry performed in patients consulting for urinary disorders. The stimulation technique will be identical as described previously. Finally, the modulation of spinal motoneurons excitability according to the degree of bladder filling will be assessed by modelling the BCR stimulus-response curves, before and during a cystometry.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bulbocavernosus reflex assessment | – | Other: Observational study : no interventionPatients over 18 years old, consulting in neuro-urology department for urinary, anorectal or genito-sexual disorders. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who will be referred to our specialized neuro-urology service for electrophysiological and urodynamic explorations
Key inclusion criteria (3 listed)
- 18 years old minimum
- Subjects with spinal cord injury or multiple sclerosis, requiring an electrophysiological and urodynamic explorations in our neuro-urology specialized department, with a strictly supra-sacral central neurological condition.
- Subjects with stress urinary incontinence (SUI) requiring perineal explorations including a cystometry and a perineal EMG.
Key exclusion criteria (2 listed)
- Subjects with peripheral neurological impairment (cauda equina syndrome, medullary cone syndrome, advanced diabetes)
- Subjects who received a treatment by injection of intra-detrusorian botulinum toxin in the last 6 months.
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 |
|---|---|---|
| Observational study : no interventionObservational study : no intervention, only exporting data | Other | Bulbocavernosus reflex assessment |
Primary outcome
Variation of the recruitment slope according to the degree of bladder repletion
Time frame: 1 day
For each patient, an assessment of spinal motoneuron excitability by using the area under the motor response curve of the bulbocavernous reflex will be performed before starting the cystometry (empty bladder) and during urgent urination needs (also during the cystometry) to determine an alpha angle of the recruitment curve. The primary outcome is the variation in this alpha coefficient.
2 secondary outcomes
Comparison of the variation of recruitment slope according to the bladder repletion : (empty bladder - B1) versus (B1-B3) variation
Time frame: 1 day
Influence of neurological disease on spinal motoneuron excitability
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
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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.
Gérard Amarenco, PHD principal investigator
Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France
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 Spasticity, Muscle, run by Pierre and Marie Curie University at 1 site in France.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 18 Feb 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Variation of the recruitment slope according to the degree of bladder repletion (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2022.