A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development

Spasticity as Sequela of Stroke Clinical Trial

— EPITOME  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06055725
• Other study ID #: CLIN-52120-458
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: January 1, 2027

Study information

• Verified date: April 2024
• Source: Ipsen
• Contact: Ipsen Clinical Study Enquiries
• Phone: See e mail
• Email: clinical.trials[@]ipsen.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1051
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Participant must be aged 18 to 85 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

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity as Sequela of Stroke
• Stroke

Locations

Country	Name	City	State
France	CHU Bordeaux-Hopital Pellegrin	Bordeaux
France	CHU de Caen	Caen
France	CHU de Rennes, Hopital de Pontchaillou	Rennes
France	Hospices Civils de Lyon (HCL) - Hopital Henry Gabrielle	Saint-Genis-Laval
Germany	Universitaetsklinikum Essen	Essen
Germany	Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel	Kiel
Germany	Universitaetsklinikum Schleswig-Holstein Campus Luebeck	Luebeck
Germany	Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz	Mainz
Italy	Azienda Ospedaliero Universitaria OO RR di Foggia	Foggia
Italy	AOU maggiore della Carita'	Novara
Italy	AOU San giovanni di Dio e Ruggi d'aragona Univ. di Salerno	Salerno
Italy	Neurological Rehabilitation Unit- Policlinico Borgo Roma.	Verona
Spain	Hospital Mutua De Terrassa	Barcelona
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Complexo Hospitalario Universitario De Vigo - Hospital Do Mexoeiro	Vigo
Sweden	Angelholm Northern Hospital	Ängelholm
Sweden	Sodra Alvsborgs Sjukhus	Borås
Sweden	Skane University Hospital	Malmö
Sweden	Karnsjukhuset Skaraborg	Skövde
United Kingdom	University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH)	Leicester
United Kingdom	The Walton Centre	Liverpool
United Kingdom	South Tees Hospitals Foundation Nhs Trust	Middlesbrough
United Kingdom	Nottingham University Hospitals NHS Trust - Nottingham City Hospital	Nottingham
United States	Emory University Merge	Atlanta	Georgia
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts
United States	The University Of Texas Southwestern Medical Center	Dallas	Texas
United States	Duke University School of Medicine	Durham	North Carolina
United States	Moss Rehab	Elkins Park	Pennsylvania
United States	University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)	Florida City	Florida
United States	Medstar Health Research Institute, Inc	Hyattsville	Maryland
United States	University Of California, Los Angeles Medical Center	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Methodist Physicians Clinic	Omaha	Nebraska
United States	Mayo Clinic	Rochester	Minnesota
United States	University Of Utah	Salt Lake City	Utah
United States	The University of Texas Health Science Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants at the Clinical Confirmation Visit (CCV) who have problematic spasticity and who the investigator considers would benefit from pharmacological therapy	This is based on the investigator's clinical judgement and could include spasticity characterised by any of the following criteria aligned with the World Health Organization International Classification of Functioning, Disability and Health in three dimensions: Impairment, Activity limitations & Restriction on participation.	At the Clinical Confirmation Visit (CCV) up to maximum 18 months
Secondary	Distribution of National Institutes of Health Stroke Scale (NIHSS) scores	Including description of score for each physical item (arm and leg motor scores) and total physical item score National Institutes of Health Stroke Scale (NIHSS) is a 15-item impairment scale, intended to evaluate neurologic outcome and degree of recovery for patients with stroke. The scale assesses level of consciousness, extraocular movements, visual fields, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria), and hemi-inattention (neglect) (Lyden, Lu, & Jackson, 1999; Lyden, Lu, & Levine, 2001). The higher the NIHSS score the worse the outcome for the participant. If the participant has a score greater than '0' they will satisfy Inclusion Criteria number 3.	At enrollment
Secondary	Percentage of participants who develop signs of possible spasticity		At Week 2, Month 1, Month 2, and every 3 months up to Month 12.
Secondary	Percentage of participants who develop clinically confirmed spasticity		Week 2 to Month 14
Secondary	Time from first ever stroke to detection of signs of possible spasticity		Week 2 to Month12
Secondary	Time from first ever stroke to onset of clinically confirmed spasticity		Week 2 to Month 14
Secondary	Time from first-ever stroke to onset of clinically confirmed problematic spasticity		Week 2 to Month 18
Secondary	Description of signs of possible spasticity from the Post-stroke Spasticity Monitoring Questionnaire (PSMQ)	Post-stroke Spasticity Monitoring Questionnaire (PSMQ) is a modified version (in local language) of a published 13-item patient reported screening questionnaire designed as a practical, easy-to-use tool to enable health care providers to identify patients with spasticity in need of treatment in routine clinical practice. The PSMQ will have an additional (14th) question for the participant to answer only if he/she has a total score for the first 13 questions of > 0 and has given an identical pattern of responses for any previously answered questionnaire which led to a F2F visit where a result of Modified Ashworth Scale (MAS) = 0 was obtained. The higher the PSMQ or MAS score is the worse the outcome for the participant.	At Week 2, Month 1, Month 2, and every 3 months up to Month 12.
Secondary	MAS distribution at the CCV (overall and distribution by timing post-stroke)		Week 2 to Month 14
Secondary	Distribution of spasticity (arm/leg, unilateral/bilateral, affected muscle groups) at the CCV		Week 2 to Month 14
Secondary	Severity of spasticity by Modified Ashworth Scale (MAS) at the CCV		Week 2 to Month 14
Secondary	MAS distribution (overall and distribution by timing post stroke) at the CCV	MAS score per joint/muscle group and MAS total score by limb	At Week 2, Month 1, Month 2, and every 3 months up to Month 14.
Secondary	MAS distribution of problematic spasticity at the CCV (overall and distribution by timing post-stroke)		Week 2 to Month 18
Secondary	Distribution of problematic spasticity (arm/leg, unilateral/bilateral, affected muscle groups) Severity of problematic spasticity by MAS at the CCV		Week 2 to Month 18
Secondary	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	Participants with clinically confirmed spasticity (MAS > 0 in any muscle group of arm and/or leg) at the CCV will be asked to complete the SF-36 health survey to assess their general health and wellbeing. The SF-36 is a generic, multipurpose short form survey consisting of 36 questions. Most of the questions are answered based on how the participant has been feeling over the previous 4 weeks.	Week 2 to Month 14
Secondary	Percentage of participants who develop problematic spasticity at the time of the confirmed diagnosis of spasticity at CCV		Week 2 to Month 14
Secondary	Percentage of participants who develop problematic spasticity		At CCV and 4 months after the CCV
Secondary	Stroke types	In terms of side (Left/Right), aetiology (Ischaemic/Haemorrhagic), and Bamford/Oxford classification (Total Anterior Circulation (TAC), Partial Anterior Circulation (PAC), Lacunar syndrome (LAC), Posterior Circulation syndrome (POC)).	Week 2 to Month 14