Effectiveness of Botulinum Toxin in Freezing of Gate in Parkinson's Disease Walking in Parkinson's Disease.

NCT06094309 | Unknown

• 1 other identifier: CHULC.CI.431.2022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Freezing of gait is a symptom of Parkinson's disease (PD) that becomes more evident with the evolution of the disease, and which presents an important difference compared to the other signs and symptoms: does not respond adequately to dopaminergic therapy, which calls into question its pathophysiology. In this sense, and through empirical experience, it has been noted that freezing responds to cueing techniques (visual, sensory motor, auditory tricks, among others) which suggests a similarity with dystonic pathology. This similarity could be the basis of a common response to botulinum toxin (BT). Objectives: This study aims to understand whether BT is an effective therapy for freezing gait in patients with Parkinson's disease. Methodology: This is a prospective parallel study with therapeutic intervention, controlled by placebo, double blind. The randomization of groups will be stratified. The population will be recruited from from the CHLC movement disorders consultation, and that meets the following inclusion criteria: Parkinson's disease with freezing of gait, scoring \> 1 at point 2.13 on the scale MDS-UPDRS and be responsive to cueing techniques, with severity of Parkinson's disease rated 3 or 4 on the Hoehn \& Yahr scale. The BT injection will be performed by a doctor with experience in this therapy, with 100 Units (U) of type A BT, bilaterally, in the flexor muscle of the thigh, once, with replacement of the same ampoules with saline in controls. To the Patient assessments will take place over 4 months, weekly by telephone using a questionnaires on freezing and the notion of clinical improvement (FOGQ and SCGIC, respectively) and monthly in person with objective assessments using the MDS-UPDRS scales - part III motor assessment, Timed Up \& Go and Two Minute Walk.

Conditions

Freezing of Gate; Parkinson Disease; Botulinum Toxin

Outcome Measures

Primary Outcomes (3)

• Variation Unified Parkinson's Disease Rating Scale (MDS-UPDRS8)

  which is defined as fever (auricular temperature \>38ºC) and elevation of CRP (\> 75 mg/L), during the first 3 days after operation.

  for 4 months after the study

• Variation Escala "Timed Up & Go"11

  20% improvement in completion time in any reevaluations;

  for 4 months after the study

• Variation Escala Two Minutes Walk12

  20% improvement in the distance covered in any reevaluations;

  for 4 months after the study

Study Arms (2)

Active Comparator: botulinum toxin

ACTIVE COMPARATOR

The botulinum toxin injection will be carried out by a doctor with experience in this therapeutic modality, which in turn is not part of the group of doctors who observe patients in the initial and subsequent phases. 100 Units (U) of botulinum toxin type A, in each lower limb (200 U in total), in muscle proximal thigh, once, at a moment that will be defined as T0. This group of 10 participans.

Drug: Botulinum toxin type A injection

Active Comparator: Placebo

PLACEBO COMPARATOR

In the control group, patients will be subject to the same protocol, with the difference in that the injections will be saline, although they look the same on the outside. You doctors carrying out therapy and evaluating progress during face-to-face visits will not have access to the distribution of groups. This group of 10 participans.

Drug: Botulinum toxin type A injection

Interventions

Botulinum toxin type A injection DRUG

The BT injection will be performed by a doctor with experience in this therapy, with 100 Units (U) of type A BT, bilaterally, in the flexor muscle of the thigh, once, with replacement of the same ampoules with saline in controls. To the Patient assessments will take place over 4 months, weekly by telephone using a questionnaires on freezing and the notion of clinical improvement (FOGQ and SCGIC, respectively) and monthly in person with objective assessments using the MDS-UPDRS scales - part III motor assessment, Timed Up \& Go and Two Minute Walk.

Active Comparator: Placebo; Active Comparator: botulinum toxin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Centro Hospitalar de Lisboa Central: lead

Study Sites (1)

Maria Margarida Grilo da Silva Dias

Lisbon, 1150-199, Portugal

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: June 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)