CLINICAL EFFECT OF BOTULINUM TOXIN TYPE A IN TREATMENT OF SPASTICITY

Sponsor

Università degli Studi del Piemonte Orientale "Amedeo Avogadro" (Other)

Overall Status

Recruiting

CT.gov ID

NCT04673240

Collaborator

Ipsen (Industry), Azienda Ospedaliero Universitaria Maggiore della Carita (Other), SIRN (Other)

Enrollment

Location

39.1

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spasticity Brain Injuries Spinal Cord Injuries Multiple Sclerosis	Drug: Botulinum toxin type A injection

Study Design

Study Type:

Observational

Anticipated Enrollment :

70 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Mar 29, 2019

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Jun 30, 2022

Outcome Measures

Primary Outcome Measures

Modified Ashworth Scale (MAS) [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)

Secondary Outcome Measures

Global Assessment of Efficacy scale) [1 month and 3 months after boNT-A injection]
Evaluation of treatment goal achievement by the physicians, patients and caregivers at 1 and 3 months after BoNT-A injection
active range of motion [e, 1, 3 and 6 months or before new BoNT-A injection]
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.
passive range of motion [e, 1, 3 and 6 months or before new BoNT-A injection]
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.
Numeric Rating Scale for pain [, 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection]
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).
EQ5-D [1, 3 and 6 months after BoNT-A or before the new BoNT-A injection]
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.
interval of time between BoNT-A reinjections [3-6 months]
Documentation of the interval of time between reinjections will be assessed during 6-months follow up (if applicable)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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