Assessment of the Excitability of Spinal Motoneurons Using Stimulus-response Curves of the Bulbocavernosus Reflex

NCT04022187 | Completed

• 1 other identifier: PGRC 001 GREEN
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Spasticity, Muscle

Keywords

Bulbocavernosus reflex; Spasticity assessment; Motoneurone excitability; Stimulus-response curves

Outcome Measures

Primary Outcomes (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.

  1 day

Secondary Outcomes (2)

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

  1 day

• Influence of neurological disease on spinal motoneuron excitability

  1 day

Study Arms (1)

Bulbocavernosus reflex assessment

Patients over 18 years old, consulting in neuro-urology department for urinary, anorectal or genito-sexual disorders.

Other: Observational study : no intervention

Interventions

Observational study : no intervention OTHER

Observational study : no intervention, only exporting data

Bulbocavernosus reflex assessment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients who will be referred to our specialized neuro-urology service for electrophysiological and urodynamic explorations

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pierre and Marie Curie University: lead

Study Sites (1)

Department of neuro-urology, hôpital Tenon

Paris, 75020, France

Location

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gérard Amarenco, PHD

  Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neuro-Urology department, Tenon Hospital

Study Record Dates

• First Submitted: July 13, 2019
• First Posted: July 17, 2019
• Study Start: July 11, 2019
• Primary Completion: July 11, 2019
• Study Completion: September 30, 2019
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

FR (1)