Spasticity as Sequela of StrokeCOLOSSEONCT05379413
Observational Longitudinal Study on the Outbreak and Management of Stroke Related Spasticity
An observational study of Spasticity as Sequela of Stroke, run by Campus Bio-Medico University at 4 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity as Sequela of Stroke
- What is being tested?
- Botulinum toxin type A
- Type of treatment
- Injection or infusion
- How many people
- 960 participants
- Where
- 4 sitesItaly
- Study dates
- 1 Jun 2022to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients suffering for ischemic stroke with upper limb involvement treated at the Lazio region (Italy) stroke units.
Who may be able to join
- Ischemic stroke with onset not far than 10 days before the enrollment
- BoNT naive
- Ability to sign the informed consent
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Italy4 sites
ASL RM 1 San Filippo Neri Hospital
Rome, Lazio, 00100
Maria Concetta Altavista, MD, mc.altavista@gmail.com
Sapienza University of Rome - Stroke Unit
Rome, Lazio, 00100
Danilo Toni, MD, danilo.toni@uniroma1.it
Sapienza University of Rome
Rome, Lazio, 00100
Antonio Suppa, MD, antonio.suppa@uniroma1.it
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Lazio, 00128
Massimo Marano, MD, m.marano@policlinicocampus.it
About this study
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
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
- Being tested
- Botulinum toxin type A
- Keywords
- Botulinum neurotoxin type A (BoNT-A), Stroke, Rehabilitation, Post-Stroke Spasticity (PSS)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum neurotoxin (BoNT) Type A injection with either OnaBoNT-A, AboBoNT-A, IncoBoNT-A
| Study group | Role | What they receive |
|---|---|---|
| Early BoNT treatment | Patients with PSS treated with BoNT within the first Quartile of injection timing distribution Receives: Drug: Botulinum toxin type A | |
| Late BoNT treatment | Patients with PSS treated with BoNT within the third Quartile of injection timing distribution Receives: Drug: Botulinum toxin type A | |
| Not treated with BoNT | Natural controls with PSS not treated with BoNT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0-24 months
Secondary outcomes (1)
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
Measured: 3-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spasticity as Sequela of StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Marano, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379413
- Sponsor's protocol ID
- COLOSSEO-BoNT
- Acronym
- COLOSSEO
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33551975Wissel 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.
PubMed 32184753Picelli 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.
PubMed 34073918Opheim 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.
PubMed 26276377Marano 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.
PubMed 38950995
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05379413
- Acronym / sponsor ID
- COLOSSEO / COLOSSEO-BoNT
- Conditions
- Spasticity as Sequela of Stroke
- Keywords
- Botulinum neurotoxin type A (BoNT-A), Stroke, Rehabilitation, Post-Stroke Spasticity (PSS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early BoNT treatment | – | Drug: Botulinum toxin type APatients with PSS treated with BoNT within the first Quartile of injection timing distribution |
| Late BoNT treatment | – | Drug: Botulinum toxin type APatients with PSS treated with BoNT within the third Quartile of injection timing distribution |
| Not treated with BoNT | – | –Natural controls with PSS not treated with BoNT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients suffering for ischemic stroke with upper limb involvement treated at the Lazio region (Italy) stroke units.
Key inclusion criteria (3 listed)
- Ischemic stroke with onset not far than 10 days before the enrollment
- BoNT naive
- Ability to sign the informed consent
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type ABotulinum neurotoxin (BoNT) Type A injection with either OnaBoNT-A, AboBoNT-A, IncoBoNT-A | Drug | Early BoNT treatment, Late BoNT treatment |
Primary outcome
Upper limb post stroke-spasticity development
Time frame: 0-24 months
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)
1 secondary outcome
Post-Stroke Spasticity in early vs late treatment
Time frame: 3-24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Background: PubMed 33551975Zeng 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.
- Background: PubMed 32184753Wissel 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.
- Background: PubMed 34073918Picelli 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.
- Background: PubMed 26276377Opheim 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.
- Derived from this study: PubMed 38950995Marano 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.
- Individual participant dataSharing planned: No
Related trials for Spasticity as Sequela of Stroke
Active, not recruitingObservational study
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
Recruiting
Cryoneurolysis for Spasticity Treatment: Long-term Clinical Outcomes and Mechanisms in the Central Nervous System
Spasticity as Sequela of Stroke
Not yet recruitingPhase 4
Phenol and Botulinum Toxin vs Botulinum Toxin Alone for Post-Stroke Upper-Limb Spasticity
Spasticity as Sequela of Stroke
Not yet recruiting
Improving STEP in Stroke Patients
Stroke, Hemiplegia Following Ischemic Stroke
Recruiting
Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy
Spasticity as Sequela of Stroke, Spastic Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasticity as Sequela of Stroke, run by Campus Bio-Medico University at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Massimo Marano, MD (+3906225411220, m.marano@policlinicocampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper limb post stroke-spasticity development (time frame: 0-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05379413, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.