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

Campus Bio-Medico University of Rome

Status: Not yet enrolling

Conditions: Spasticity as Sequela of Stroke

Treatments: Drug: Botulinum toxin type A

Study type: Observational

Funder types: Other

Identifiers

NCT05379413

COLOSSEO-BoNT

Details and patient eligibility

About

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

Enrollment: 960 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

960 participants in 3 patient groups

Early BoNT treatment

Description:

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

Treatment:

Drug: Botulinum toxin type A

Late BoNT treatment

Description:

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

Treatment:

Drug: Botulinum toxin type A

Not treated with BoNT

Description:

Natural controls with PSS not treated with BoNT