Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04022187
Other study ID # PGRC 001 GREEN
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 11, 2019
Est. completion date September 30, 2019

Study information

Verified date February 2022
Source Pierre and Marie Curie University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 (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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 30, 2019
Est. primary completion date July 11, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observational study : no intervention
Observational study : no intervention, only exporting data

Locations

Country Name City State
France Department of neuro-urology, hôpital Tenon Paris

Sponsors (1)

Lead Sponsor Collaborator
Pierre and Marie Curie University

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Comparison of the variation of recruitment slope according to the bladder repletion : (empty bladder - B1) versus (B1-B3) variation 1 day
Secondary Influence of neurological disease on spinal motoneuron excitability comparison of the variation of the recruitment slope observed in neurological subjects versus non-neurological subjects. 1 day
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT03908580 - MEDITOXIN® Treatment in Subjects With Post-Stroke Upper Limb Spasticity Phase 4
Not yet recruiting NCT04550793 - Using Shear Wave Ultrasound Elastography for Follow up After Anti-spastic Intervention Among Stroke Patients
Recruiting NCT05432999 - Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury N/A
Completed NCT05687097 - Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury
Active, not recruiting NCT05562453 - Performance and Long-term Safety of FlowOx2.0™ in Patients With Multiple Sclerosis - Impact on Spasticity and Pain N/A
Recruiting NCT06214975 - EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE 2) N/A
Recruiting NCT05464160 - Focal Muscular Vibration in Patients With Severe Acquired Brain Injury N/A
Completed NCT04130295 - Influence of Wearable Intensive Nerve Stimulation on Spasticity and Function in Persons With Spinal Cord Injury N/A
Recruiting NCT06070233 - Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy N/A
Completed NCT03747900 - Dry Needling and Botulinum Toxin in the Management of Poststroke Spasticity N/A
Completed NCT03307135 - Medical Spastic Patient Machine Interface MSPMI : Biomechanical and Electrophysiological Assessment of the Triceps Surae Spasticity N/A
Recruiting NCT05070780 - Neurophysiological Evaluation of Muscle Tone
Recruiting NCT04620707 - RGS@Home: Personalized 24/7 Home Care Post-stroke N/A
Recruiting NCT06109129 - Investıgatıon Of The Effectıveness Of The Mollıı Suıt In Chıldren Wıth Ambulatory Cerebral Palsy N/A
Enrolling by invitation NCT05598736 - Performance and Long-term Safety of FlowOx2.0™, Multiple Sclerosis, Spasticity and Pain N/A
Completed NCT05103202 - Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin
Active, not recruiting NCT05626790 - Effects of PNF and Static Stretching on Architecture and Viscoelastic Properties of Hemiplegic Elbow N/A
Recruiting NCT04904016 - Pilot Investigation to Evaluate FlowOx2.0™ for Experimental Treatment of Spasticity N/A
Withdrawn NCT05887479 - The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity Phase 4