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

NCT ID: NCT05379413

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 960 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2025-06-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Early BoNT treatment

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

Botulinum toxin type A

Intervention Type: DRUG

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

Late BoNT treatment

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

Botulinum toxin type A

Intervention Type: DRUG

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

Not treated with BoNT

Natural controls with PSS not treated with BoNT

No interventions assigned to this group

Interventions

Botulinum toxin type A

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Campus Bio-Medico University

OTHER

Sponsor Role: lead

Responsible Party

Massimo Marano

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ASL RM 1 San Filippo Neri Hospital

Rome, Lazio, Italy

Sapienza University of Rome - Stroke Unit

Rome, Lazio, Italy

Sapienza University of Rome

Rome, Lazio, Italy

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Lazio, Italy

Countries

Italy

Central Contacts

Massimo Marano, MD

Role: CONTACT

m.marano@policlinicocampus.it

+3906225411220

Facility Contacts

Maria Concetta Altavista, MD

Role: primary

mc.altavista@gmail.com

Danilo Toni, MD

Role: primary

danilo.toni@uniroma1.it

Antonio Suppa, MD

Role: primary

antonio.suppa@uniroma1.it

Massimo Marano, MD

Role: primary

m.marano@policlinicocampus.it

References

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.

Reference Type: BACKGROUND

PMID: 33551975 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32184753 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34073918 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26276377 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38950995 (View on PubMed)

Other Identifiers

COLOSSEO-BoNT

Identifier Type: -

Identifier Source: org_study_id