NCT04673240

CLINICAL EFFECT OF BOTULINUM TOXIN TYPE A IN TREATMENT OF SPASTICITY

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Università degli Studi del Piemonte Orientale Amedeo Avogadro · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spasticity
• Brain Injuries
• Spinal Cord Injuries
• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Botulinum toxin type A injection	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.

Timeline

• Start date: 2019-03-29
• Primary completion: 2021-12-31
• Completion: 2022-06-30
• First posted: 2020-12-17
• Last updated: 2020-12-17

Locations

1 site across 1 country: Italy