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

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 Overview

• Status: Unknown
• Conditions: Multiple Sclerosis; Brain Injuries; Spinal Cord Injuries; Spasticity
• Intervention / Treatment: Drug: Botulinum toxin type A injection

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• Italy
  • Novara, Italy, 28100
    • Recruiting
    • Azienda Ospedaliero Universitaria Maggiore della Carita
    • Contact: Alessio Baricich, MDPhD; Phone Number: 03213734805; Email: alessio.baricich@maggioreosp.novara.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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).	, 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.	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)	3-6 months

Collaborators and Investigators

• Sponsor: Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
• Collaborators: Ipsen; Azienda Ospedaliero Universitaria Maggiore della Carita; SIRN
• Investigators: Study Chair: Alessio Baricich, Università del Piemonte orientale "Amedeo Avogadro"

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: December 12, 2020
• First Submitted That Met QC Criteria: December 12, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 12, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Spinal Cord Diseases; Muscle Hypertonia; Multiple Sclerosis; Sclerosis; Brain Injuries; Wounds and Injuries; Spinal Cord Injuries; Muscle Spasticity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: NSS_BoNT-A

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No