Clinical trial NCT06055725: A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development
Official title: A Prospective, Multicountry Study to Estimate the Incidence of and Provide a Best Practice Model for Monitoring the Development of Post-Stroke Spasticity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spasticity as Sequela of Stroke
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 1051
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Main Population will be participants aged 18 to 90 years with confirmed paresis within 2 weeks after a first-ever clinical stroke that has occurred within the past 4 weeks

Brief summary: This study will monitor patients during the first year following their stroke.

Stroke is a very serious condition where there is a sudden interruption of blood flow in the brain.

The main aim of the study will be to find out how many of those who experience their first-ever stroke then go on to develop spasticity that would benefit from treatment with medication.

Spasticity is a common post-stroke condition that causes stiff or ridged muscles.

The results of this study will provide a standard guideline on the best way to monitor the development of post-stroke spasticity.


Eligibility criteria: Inclusion Criteria:

* Participant must be aged 18 to 90 years at the time of providing informed consent
* First-ever clinical stroke, defined according to World Health Organization criteria as rapidly developing clinical signs of focal (at times global) disturbance of cerebral function lasting more than 24 hours, within the past 4 weeks;
* Confirmed paresis of the arms and/or legs which does not resolve within 1 day, according to the NIHSS score (a score of \> 0 on Question 5 or 6 of the scale) within 2 weeks after the stroke
* Capable of giving informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

Exclusion Criteria:

* Upper or lower extremity functional impairment prior to stroke per investigator judgement (e.g., modified Rankin Scale \>2);
* Presence of significant/major neurological impairment that might affect muscle tone (other than limb paresis);
* Severe multi-impairment or diminished physical condition before stroke that could have caused paresis/spasticity/motor deficit per investigator judgement;
* Life expectancy of less than 12 months as a result of severity of stroke or other illnesses (e.g. cardiac disease, malignancy, etc.)
* Participation in any interventional study

Primary outcomes:
measure: Percentage of participants at the Clinical Confirmation Visit (CCV) who have problematic spasticity and who the investigator considers would benefit from pharmacological therapy
timeFrame: At the Clinical Confirmation Visit (CCV) up to maximum 18 months
Secondary outcomes:
measure: Distribution of National Institutes of Health Stroke Scale (NIHSS) scores
timeFrame: At enrollment
measure: Percentage of participants who develop signs of possible spasticity
timeFrame: At Week 2, Month 1, Month 2, and every 3 months up to Month 12.
measure: Percentage of participants who develop clinically confirmed spasticity
timeFrame: Week 2 to Month 14
measure: Time from first ever stroke to detection of signs of possible spasticity
timeFrame: Week 2 to Month12
measure: Time from first ever stroke to onset of clinically confirmed spasticity
timeFrame: Week 2 to Month 14
measure: Time from first-ever stroke to onset of clinically confirmed problematic spasticity
timeFrame: Week 2 to Month 18
measure: Description of signs of possible spasticity from the Post-stroke Spasticity Monitoring Questionnaire (PSMQ)
timeFrame: At Week 2, Month 1, Month 2, and every 3 months up to Month 12.
measure: MAS distribution at the CCV (overall and distribution by timing post-stroke)
timeFrame: Week 2 to Month 14
measure: Distribution of spasticity (arm/leg, unilateral/bilateral, affected muscle groups) at the CCV
timeFrame: Week 2 to Month 14
measure: Severity of spasticity by Modified Ashworth Scale (MAS) at the CCV
timeFrame: Week 2 to Month 14
measure: MAS distribution (overall and distribution by timing post stroke) at the CCV
timeFrame: At Week 2, Month 1, Month 2, and every 3 months up to Month 14.
measure: MAS distribution of problematic spasticity at the CCV (overall and distribution by timing post-stroke)
timeFrame: Week 2 to Month 18
measure: Distribution of problematic spasticity (arm/leg, unilateral/bilateral, affected muscle groups) Severity of problematic spasticity by MAS at the CCV
timeFrame: Week 2 to Month 18
measure: Distribution of 36-Item Short-form Health Survey (SF-36) quality of life questionnaire scores in participants with clinically confirmed spasticity[c] at the CCV
timeFrame: Week 2 to Month 14
measure: Percentage of participants who develop problematic spasticity at the time of the confirmed diagnosis of spasticity at CCV
timeFrame: Week 2 to Month 14
measure: Percentage of participants who develop problematic spasticity
timeFrame: At CCV and 4 months after the CCV
measure: Stroke types
timeFrame: Week 2 to Month 14
Other outcomes:
Locations:
city: Anderson
country: United States
facility: Loma Linda
state: California
city: Los Angeles
country: United States
facility: University Of California, Los Angeles Medical Center
state: California
city: Florida City
country: United States
facility: University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
state: Florida
city: Atlanta
country: United States
facility: Emory University Merge
state: Georgia
city: Hyattsville
country: United States
facility: Medstar Health Research Institute, Inc
state: Maryland
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: Omaha
country: United States
facility: Methodist Physicians Clinic
state: Nebraska
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
city: Elkins Park
country: United States
facility: Moss Rehab
state: Pennsylvania
city: Dallas
country: United States
facility: The University Of Texas Southwestern Medical Center
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: University Of Utah
state: Utah
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Bordeaux
country: France
facility: CHU Bordeaux-Hopital Pellegrin
city: Caen
country: France
facility: CHU de Caen
city: Rennes
country: France
facility: CHU de Rennes, Hopital de Pontchaillou
city: Saint-Genis-Laval
country: France
facility: Hospices Civils de Lyon (HCL) - Hopital Henry Gabrielle
city: Saint-Jacques
country: France
facility: CHU Nantes
city: Altenburg
country: Germany
facility: Klinikum Altenburger Land GmbH
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Luebeck
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
city: Foggia
country: Italy
facility: Azienda Ospedaliero Universitaria OO RR di Foggia
city: Novara
country: Italy
facility: AOU maggiore della Carita'
city: Salerno
country: Italy
facility: AOU San giovanni di Dio e Ruggi d'aragona Univ. di Salerno
city: Verona
country: Italy
facility: Neurological Rehabilitation Unit- Policlinico Borgo Roma.
city: Verona
country: Italy
facility: Neuromotor And Cognitive Rehabilitation Research Centre; Dep. Of Neurological, Neuropsychological, Morphological And Movement Sciences; Univ. Of Verona - Neurological Rehabilitation Unit- Policlinico Borgo Roma
city: Barcelona
country: Spain
facility: Hospital Mutua De Terrassa
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Vigo
country: Spain
facility: Complexo Hospitalario Universitario De Vigo - Hospital Do Mexoeiro
city: Borås
country: Sweden
facility: Sodra Alvsborgs Sjukhus
city: Malmö
country: Sweden
facility: Skane University Hospital
city: Skövde
country: Sweden
facility: Karnsjukhuset Skaraborg
city: Ängelholm
country: Sweden
facility: Angelholm Northern Hospital
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH)
city: Liverpool
country: United Kingdom
facility: The Walton Centre
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospitals Foundation Nhs Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust - Nottingham City Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: