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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • Department of neuro-urology, hôpital Tenon

    Paris, 75020

Other trials in France

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.

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 groups in NCT04022187
Study groupRoleWhat they receive
Bulbocavernosus reflex assessmentPatients 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.

  1. 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)
  1. Comparison of the variation of recruitment slope according to the bladder repletion : (empty bladder - B1) versus (B1-B3) variation

    Measured: 1 day

  2. 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.

  1. First posted17 Jul 2019
  2. Study start11 Jul 2019
  3. Primary completion11 Jul 2019
  4. Study completion30 Sep 2019

Resources

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)
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

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.

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