SpasticityNCT04673240
CLINICAL EFFECT OF BOTULINUM TOXIN TYPE A IN TREATMENT OF SPASTICITY
An observational study of Spasticity and Brain Injuries, run by Università degli Studi del Piemonte Orientale Amedeo Avogadro at 1 site in Italy.
Trial summary
Spasticity has been defined as a disorder of the sensorimotor system characterized by a velocity-dependent increase in tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity, Brain Injuries, Spinal Cord Injuries
- What is being tested?
- Botulinum toxin type A injection
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 29 Mar 2019to 30 Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with spasticity as a consequence of traumatic brain injury, spinal cord injury or MS, treated with Botulinum Toxin type A.
Who may be able to join
- Age >18 years
- Spasticity as a consequence of traumatic brain injury, spinal cord injury or MS (documented by clinical records)
- Muscle tone graded at least 1+ on the modified Ashworth scale in the relevant joints of the affected limb(s), which requires medical intervention
- BoNT naïve or pre-treated with any BoNT product. If previously treated with any BoNT, at least a 4 months interval between last injection and inclusion
Who cannot join
- Presence of fixed contractures or bony deformities in the affected limb
- Changes in any oral antispastic medications or specific physiotherapy regimen <4m before study entry or during the study.
- Other neurological or orthopaedic conditions involving the affected limbs.
- Sensitivity to BoNT-A or to its excipients
- Other contraindications as given in the local SmPC for BoNT-A
Trial locations and contacts
1 site in 1 country.
Roberta Carozzi contact
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100
Alessio Baricich, MDPhD, 03213734805, alessio.baricich@maggioreosp.novara.it
About this study
Official title: CLINICAL EFFECT OF BOTULINUM TOXIN TYPE A IN THE TREATMENT OF SPASTICITY AFTER TRAUMATIC BRAIN INJURY, SPINAL CORD INJURY OR IN MULTIPLE SCLEROSIS PATIENTS: AN OBSERVATIONAL STUDY
Spasticity has been defined as a disorder of the sensorimotor system characterized by a velocity-dependent increase in tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex.
The treatment goal of spasticity is Medical treatment generally combines physiotherapy with medications, depending on spasticity distribution. Systemic treatments such as oral or intrathecal baclofen are generally considered in case of generalized spasticity, whereas local treatments are considered in case of focal spasticity.
Read more
Local treatments such as Botulinum Toxin type A, phenol, and alcohol present several advantages, allowing to treat of selected muscles without the risk of sedation. As stated above, they are indicated for focal spasticity but might be helpful even in the presence of generalized spasticity with identified focal goals (Bethoux et al., 2015).
In particular, Botulinum Toxin type A (BoNT-A) is considered the gold standard treatment for focal spasticity, showing a level A evidence for spasticity reduction in upper- and lower-limb spasticity (Simpson et al., 2016).
However, current evidence is mainly focused on post-stroke spasticity (Franceschini et al., 2014), whereas it is still limited in spasticity as a consequence of other aetiologies, such as spinal cord injury (SCI), traumatic brain injury (TBI), or multiple sclerosis (MS).
Interestingly, spasticity is a major concern for the rehabilitation of these patients.
The aim of this observational study is the evaluation of the clinical efficacy of BoNT-A in spasticity reduction in patients affected by neurological conditions different from post-stroke spasticity, such as SCI, TBI, and MS.
- Conditions
- Spasticity, Brain Injuries, Spinal Cord Injuries, Multiple Sclerosis
- Being tested
- Botulinum toxin type A injection
- Medical subject headings
- Muscle Spasticity, Brain Injuries, Spinal Cord Injuries, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A injectionDrug
Adult patients with spasticity due to traumatic brain injury, spinal cord injury, or MS, treated with Botulinum Toxin type A.
As this is a non-interventional study, no diagnostic, therapeutic, or experimental intervention is involved. Subjects will receive clinical assessments, medications, and treatments solely as determined by their study physician.
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale (MAS)
Percentage of patients with at least 1 point reduction of MAS in any treated muscle, 1 month after BoNT-A injection injection of Botulinum toxin A (responders)
Measured: 1 month
Secondary outcomes (6)
Global Assessment of Efficacy scale)
Evaluation of treatment goal achievement by the physicians, patients and caregivers at 1 and 3 months after BoNT-A injection
Measured: 1 month and 3 months after boNT-A injection
active range of motion
Documentation of active range of motion (a-ROM) for the treated joints in the overall study population at baseline, 1, 3 and 6 months or before new BoNT-A injection using a handheld goniometer.
Measured: e, 1, 3 and 6 months or before new BoNT-A injection
passive range of motion
Documentation of passive range of motion (p-ROM) for the treated joints in the overall study population at baseline, 1, 3 and 6 months or before new BoNT-A injection using a handheld goniometer.
Measured: e, 1, 3 and 6 months or before new BoNT-A injection
Numeric Rating Scale for pain
Pain will be assessed in the overall study population at baseline, 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection using Numeric Rating Scale (pain).
Measured: , 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection
EQ5-D
Quality of life will be assessed in the overall study population at baseline, 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection using EQ5-D questionnaire.
Measured: 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection
interval of time between BoNT-A reinjections
Documentation of the interval of time between reinjections will be assessed during 6-months follow up (if applicable)
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start29 Mar 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SpasticityStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen, Azienda Ospedaliero Universitaria Maggiore della Carita, SIRN
- Responsible party
- Principal investigator, Alessio Baricich, Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Investigators
- Alessio Baricich, Study chair, Università del Piemonte orientale "Amedeo Avogadro"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673240
- Sponsor's protocol ID
- NSS_BoNT-A
- Status last verified
- Dec 2020
- First submitted
- 12 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
Publications
Baricich A, Battaglia M, Cuneo D, Cosenza L, Millevolte M, Cosma M, Filippetti M, Dalise S, Azzollini V, Chisari C, Spina S, Cinone N, Scotti L, Invernizzi M, Paolucci S, Picelli A, Santamato A. Clinical efficacy of botulinum toxin type A in patients with traumatic brain injury, spinal cord injury, or multiple sclerosis: An observational longitudinal study. Front Neurol. 2023 Apr 6;14:1133390. doi: 10.3389/fneur.2023.1133390. eCollection 2023.
PubMed 37090974
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL EFFECT OF BOTULINUM TOXIN TYPE A IN THE TREATMENT OF SPASTICITY AFTER TRAUMATIC BRAIN INJURY, SPINAL CORD INJURY OR IN MULTIPLE SCLEROSIS PATIENTS: AN OBSERVATIONAL STUDY
- ClinicalTrials.gov ID
- NCT04673240
- Acronym / sponsor ID
- NSS_BoNT-A
- Conditions
- Spasticity, Brain Injuries, Spinal Cord Injuries, Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Università degli Studi del Piemonte Orientale Amedeo AvogadroUniversity, hospital or other
- Collaborators
- Ipsen, Azienda Ospedaliero Universitaria Maggiore della Carita, SIRN
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 17 Dec 2020 (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.
Spasticity has been defined as a disorder of the sensorimotor system characterized by a velocity-dependent increase in tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex.
The treatment goal of spasticity is Medical treatment generally combines physiotherapy with medications, depending on spasticity distribution. Systemic treatments such as oral or intrathecal baclofen are generally considered in case of generalized spasticity, whereas local treatments are considered in case of focal spasticity.
Local treatments such as Botulinum Toxin type A, phenol, and alcohol present several advantages, allowing to treat of selected muscles without the risk of sedation. As stated above, they are indicated for focal spasticity but might be helpful even in the presence of generalized spasticity with identified focal goals (Bethoux et al., 2015).
In particular, Botulinum Toxin type A (BoNT-A) is considered the gold standard treatment for focal spasticity, showing a level A evidence for spasticity reduction in upper- and lower-limb spasticity (Simpson et al., 2016).
However, current evidence is mainly focused on post-stroke spasticity (Franceschini et al., 2014), whereas it is still limited in spasticity as a consequence of other aetiologies, such as spinal cord injury (SCI), traumatic brain injury (TBI), or multiple sclerosis (MS).
Interestingly, spasticity is a major concern for the rehabilitation of these patients.
The aim of this observational study is the evaluation of the clinical efficacy of BoNT-A in spasticity reduction in patients affected by neurological conditions different from post-stroke spasticity, such as SCI, TBI, and MS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with spasticity as a consequence of traumatic brain injury, spinal cord injury or MS, treated with Botulinum Toxin type A.
Key inclusion criteria (4 listed)
- Age >18 years
- Spasticity as a consequence of traumatic brain injury, spinal cord injury or MS (documented by clinical records)
- Muscle tone graded at least 1+ on the modified Ashworth scale in the relevant joints of the affected limb(s), which requires medical intervention
- BoNT naïve or pre-treated with any BoNT product. If previously treated with any BoNT, at least a 4 months interval between last injection and inclusion
Key exclusion criteria (5 listed)
- Presence of fixed contractures or bony deformities in the affected limb
- Changes in any oral antispastic medications or specific physiotherapy regimen <4m before study entry or during the study.
- Other neurological or orthopaedic conditions involving the affected limbs.
- Sensitivity to BoNT-A or to its excipients
- Other contraindications as given in the local SmPC for BoNT-A
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 A injectionAdult patients with spasticity due to traumatic brain injury, spinal cord injury, or MS, treated with Botulinum Toxin type A. As this is a non-interventional study, no diagnostic, therapeutic, or experimental intervention is involved. Subjects will receive clinical assessments, medications, and treatments solely as determined by their study physician. | Drug | – |
Primary outcome
Modified Ashworth Scale (MAS)
Time frame: 1 month
Percentage of patients with at least 1 point reduction of MAS in any treated muscle, 1 month after BoNT-A injection injection of Botulinum toxin A (responders)
6 secondary outcomes
Global Assessment of Efficacy scale)
Time frame: 1 month and 3 months after boNT-A injection
active range of motion
Time frame: e, 1, 3 and 6 months or before new BoNT-A injection
passive range of motion
Time frame: e, 1, 3 and 6 months or before new BoNT-A injection
Numeric Rating Scale for pain
Time frame: , 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection
EQ5-D
Time frame: 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection
interval of time between BoNT-A reinjections
Time frame: 3-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Derived from this study: PubMed 37090974Baricich A, Battaglia M, Cuneo D, Cosenza L, Millevolte M, Cosma M, Filippetti M, Dalise S, Azzollini V, Chisari C, Spina S, Cinone N, Scotti L, Invernizzi M, Paolucci S, Picelli A, Santamato A. Clinical efficacy of botulinum toxin type A in patients with traumatic brain injury, spinal cord injury, or multiple sclerosis: An observational longitudinal study. Front Neurol. 2023 Apr 6;14:1133390. doi: 10.3389/fneur.2023.1133390. eCollection 2023.
Related trials for Spasticity
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
RecruitingObservational study
Evaluation of Patients With HAM/TSP
HTLV-I Infection, Tropical Spastic Paraparesis
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.
Roberta Carozzi contact
Alessio Baricich study chair
Università del Piemonte orientale "Amedeo Avogadro"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasticity and Brain Injuries, run by Università degli Studi del Piemonte Orientale Amedeo Avogadro at 1 site 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 4 inclusion and 5 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Alessio Baricich (03213734805, alessio.baricich@maggioreosp.novara.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (MAS) (time frame: 1 month). 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 NCT04673240, which also lists 1 linked publication.
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 17 Dec 2020.