Observational Longitudinal Study on the Outbreak and Management of Stroke Related Spasticity

Spasticity as Sequela of Stroke Clinical Trial

— COLOSSEO  

Official title:

Comprehensive Observational & Longitudinal Study on the Outbreak of Stroke Related Spasticity Focusing on the Early Onset Management With BoNT: The COLOSSEO-BoNT Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05379413
• Other study ID #: COLOSSEO-BoNT
• Status: Not yet recruiting
• Start date: June 1, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2022
• Source: Campus Bio-Medico University
• Contact: Massimo Marano, MD
• Phone: +3906225411220
• Email: m.marano[@]policlinicocampus.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Stroke is one of the leading cause of death and disability worldwide. Post-stroke spasticity (PSS) is outbreak after a stroke and is featured by disabling muscle stiffness. PSS could manifest in up tp 50% cases within 6 months after a stroke, especially in the upper limb. Despite it is an acknowledged condition it is insufficiently recognized and treated in clinical practice.

Focal and regional spasticity could improve with rehabilitation and in selected cases with botulinum neurotoxin (BoNT) type A injections. The latter causes muscle relaxation and fosters neuroplasticity, which is able in turn of ameliorating several patient functional aspects. Recent literature demonstrated that PSS patients treated with early BoNT (within 3 month since PSS outbreak) could improve in their clinical status better than patients with a later treatment.

An earlier recognition of PSS predictors could improve patient management. Hence, the investigators are going to perform a multicentric prospective observational real life study with BoNT, based on the best clinical practice and aimed at the early recognition and management of PSS through the identification of 1) early clinical predictors of spasticity (collected within 10 days since stroke), 2) BoNT clinical outcome relative to the timing of the treatment

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 960
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ischemic stroke with onset not far than 10 days before the enrollment

• BoNT naive

• Ability to sign the informed consent

Exclusion Criteria:

• Hypersensitivity to BoNT or BoNT related substances

• Participant of Post-stroke spasticity RCT

• Persistent and severe altered mental status or concurrent severe medical condition able to hasten the rehabilitation path.

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity as Sequela of Stroke
• Stroke

Intervention

Drug:
• Botulinum toxin type A
Botulinum neurotoxin (BoNT) Type A injection with either OnaBoNT-A, AboBoNT-A, IncoBoNT-A

Locations

Country	Name	City	State
Italy	ASL RM 1 San Filippo Neri Hospital	Roma	Lazio
Italy	Fondazione Policlinico Universitario Campus Bio-Medico	Roma	Lazio
Italy	Sapienza University of Rome	Roma	Lazio
Italy	Sapienza University of Rome - Stroke Unit	Roma	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Opheim A, Danielsson A, Alt Murphy M, Persson HC, Sunnerhagen KS. Early prediction of long-term upper limb spasticity after stroke: part of the SALGOT study. Neurology. 2015 Sep 8;85(10):873-80. doi: 10.1212/WNL.0000000000001908. Epub 2015 Aug 14. — View Citation

Picelli A, Santamato A, Cosma M, Baricich A, Chisari C, Millevolte M, Prete CD, Mazzù I, Girardi P, Smania N. Early Botulinum Toxin Type A Injection for Post-Stroke Spasticity: A Longitudinal Cohort Study. Toxins (Basel). 2021 May 24;13(6). pii: 374. doi: 10.3390/toxins13060374. — View Citation

Wissel J, Fheodoroff K, Hoonhorst M, Müngersdorf M, Gallien P, Meier N, Hamacher J, Hefter H, Maisonobe P, Koch M. Effectiveness of AbobotulinumtoxinA in Post-stroke Upper Limb Spasticity in Relation to Timing of Treatment. Front Neurol. 2020 Feb 28;11:104. doi: 10.3389/fneur.2020.00104. eCollection 2020. — View Citation

Zeng H, Chen J, Guo Y, Tan S. Prevalence and Risk Factors for Spasticity After Stroke: A Systematic Review and Meta-Analysis. Front Neurol. 2021 Jan 20;11:616097. doi: 10.3389/fneur.2020.616097. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Upper limb functionality	Comparison of functional items of upper limb functionality (arm activity measure scale, i.e. ARM-A a 0-84 scale - a higher score means a worse upper limb function) of early versus late treatments	3-24 months
Other	Quality of Life measurement	Comparison of Quality of Life (EuroQoL-5D or EQ-5D scale , 5 to 25 scale where 25 is the worst quality of life possible) of patients with early versus late treatments	3-24 months
Other	Pain measurement	Comparison of pain (Visual Analogue scale or VAS in units on a 0-10 grading system, where 10 is the worst pain possible) of patients with early versus late treatments	3-24 months
Other	Spasticity in Botulinum Toxin (BoNT) treated versus untreated patients	Comparison of modified ashworth scale (MAS) in BoNT treated versus untreated subjects (MAS is a 0 to 5 score, where 5 is the worst rigidity possible). Herein an aggregated wrist and elbow score (on a 0 - 10 scale with 10 being the worst spasticity) will be used.	3-24 months
Other	Functionality in Botulinum Toxin treated versus untreated patients	Comparison of functionality (arm activity measure, i.e. ARM-A total score, a 0 to 84 scoring system - higher score means a worse upper limb function) in BoNT treated versus untreated subjects	3-24 months
Other	Quality of life in Botulinum Toxin treated versus untreated patients	Comparison of Quality of life (EuroQoL-5D or EQ-5D scale is a 5 to 25 scale where 25 is the lower quality of life possible) in BoNT treated versus untreated patients	3-24 months
Other	Pain in Botulinum Toxin treated versus untreated patients	Comparison of pain (visual analogue scale, VAS, 0-10 scale where 10 is the worst pain possible) in BoNT treated versus untreated patients	3-24 months
Primary	Upper limb post stroke-spasticity development	Detection of a Modified Ashworth Scale (MAS) >/= 1 at the upper limb (MAS is a 0 to 5 score, with score 5 as the worst rigidity possible)	0-24 months
Secondary	Post-Stroke Spasticity in early vs late treatment	Comparison of the Modified Ashworth Scale (MAS) at the elbow and wrist (MAS is a 0 to 5 score, with score 5 as the worst rigidity possible) in early versus late treatment	3-24 months