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

NCT05379413 | Unknown DMC FDA Drug

• 1 other identifier: COLOSSEO-BoNT
• Study Type: observational
• Target: 960
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Spasticity as Sequela of Stroke

Keywords

Botulinum neurotoxin type A (BoNT-A); Stroke; Rehabilitation; Post-Stroke Spasticity (PSS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post-Stroke Spasticity in early vs late treatment

  3-24 months

Other Outcomes (7)

• Upper limb functionality

  3-24 months

• Quality of Life measurement

  3-24 months

• Pain measurement

  3-24 months

Study Arms (3)

Early BoNT treatment

Patients with PSS treated with BoNT within the first Quartile of injection timing distribution

Drug: Botulinum toxin type A

Late BoNT treatment

Patients with PSS treated with BoNT within the third Quartile of injection timing distribution

Drug: Botulinum toxin type A

Not treated with BoNT

Natural controls with PSS not treated with BoNT

Interventions

Botulinum toxin type A DRUG

Botulinum neurotoxin (BoNT) Type A injection with either OnaBoNT-A, AboBoNT-A, IncoBoNT-A

Early BoNT treatment; Late BoNT treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering for ischemic stroke with upper limb involvement treated at the Lazio region (Italy) stroke units.

You may qualify if:

• Ischemic stroke with onset not far than 10 days before the enrollment
• BoNT naive
• Ability to sign the informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (4)

ASL RM 1 San Filippo Neri Hospital

Rome, Lazio, 00100, Italy

Location

Sapienza University of Rome - Stroke Unit

Rome, Lazio, 00100, Italy

Location

Sapienza University of Rome

Rome, Lazio, 00100, Italy

Location

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Lazio, 00128, Italy

Location

Related Publications (5)

• 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.

  PMID: 33551975 BACKGROUND

• Wissel J, Fheodoroff K, Hoonhorst M, Mungersdorf 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.

  PMID: 32184753 BACKGROUND

• Picelli A, Santamato A, Cosma M, Baricich A, Chisari C, Millevolte M, Prete CD, Mazzu 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):374. doi: 10.3390/toxins13060374.

  PMID: 34073918 BACKGROUND

• 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.

  PMID: 26276377 BACKGROUND

• Marano M, Suppa A, Palmieri MG, Cecconi E, Frisullo G, Bovenzi R, Riso V, Anzini A, Brienza M, Anticoli S, Crupi D, Giovannelli M, Massimiani A, Rinalduzzi S, Morena E, Massara MC, Cupini L, Bressi F, Pilato F, Maggi L, Sauchelli D, Iezzi E, Centonze D, Aprile I, Di Lazzaro V, Toni D, Altavista MC; COLOSSEO study group. Comprehensive Observational and Longitudinal study on the Outbreak of Stroke-related Spasticity focusing on the Early Onset management with Botulinum NeuroToxin (COLOSSEO-BoNT): protocol for a real-world prospective observational study on upper limb spasticity. BMJ Open. 2024 Jul 1;14(6):e085484. doi: 10.1136/bmjopen-2024-085484.

  PMID: 38950995 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Massimo Marano, MD

CONTACT

+3906225411220; m.marano@policlinicocampus.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 18, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)