Clinical trial NCT04673240: CLINICAL EFFECT OF BOTULINUM TOXIN TYPE A IN TREATMENT OF SPASTICITY
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spasticity
Brain Injuries
Spinal Cord Injuries
Multiple Sclerosis
Lead sponsor: Università degli Studi del Piemonte Orientale Amedeo Avogadro
Sponsor class: OTHER
Collaborators: name: Ipsen
name: Azienda Ospedaliero Universitaria Maggiore della Carita
name: SIRN
First posted: 2020-12-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with spasticity as a consequence of traumatic brain injury, spinal cord injury or MS, treated with Botulinum Toxin type A.

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: 1 month
Secondary outcomes:
measure: Global Assessment of Efficacy scale)
timeFrame: 1 month and 3 months after boNT-A injection
measure: active range of motion
timeFrame: e, 1, 3 and 6 months or before new BoNT-A injection
measure: passive range of motion
timeFrame: e, 1, 3 and 6 months or before new BoNT-A injection
measure: Numeric Rating Scale for pain
timeFrame: , 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection
measure: EQ5-D
timeFrame: 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection
measure: interval of time between BoNT-A reinjections
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carità
Study officials:
affiliation: Università del Piemonte orientale "Amedeo Avogadro"
name: Alessio Baricich
role: STUDY_CHAIR
References: