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Kinematic-based BoNT-A Bilateral Upper Limb PD Therapy

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Movement disorders, Botulinum toxin type A, Tremor, Kinematics

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • PD individuals diagnosed by UK Brain Bank Criteria with stage H&Y2-3 disease
  • PD participants who are naïve to PD medications will be grouped into the "De novo" PD group
  • PD participants stable on a low dose of Levodopa or on their PD medications for at least 3 months prior to their study enrolment will be grouped into the "L-dopa" PD group
  • Participants who are botulinum toxin naïve for tremor management
  • Patients will be screened for pregnancy by the physician
  • Individuals with PD will be eligible for the study only if tremor is their primary and most bothersome symptom as determined by clinical exam and patient report denoting tremor-dominant phenotype
  • Participants must be able to provide informed consent and to complete all study assessment scales and tasks.

Exclusion Criteria:

  • History of stroke
  • History of ALS or Myasthenia Gravis
  • History of COPD or emphysema
  • Underlying arm muscle weakness or any related compartmental muscle syndrome
  • Offending medications (Lithium, valproate, steroids, amiodarone, beta-adrenergic agonists (e.g. salbutamol).
  • Persons prescribed zonisamide
  • History of allergic or side effect reaction to botulinum toxin
  • Contraindications per the BoNT-A drug monograph
  • Women reporting that they are pregnant

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

De-novo PD

L-dopa PD

Arm Description

A serotype of botulinum toxin type A (BoNT-A) that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction. BoNT-A peripherally applied using optimal parameters by intramuscular injections solely determined by biomechanical analysis of tremulous movements for tremor therapy in both upper extremity every 12 weeks over 42 weeks. BoNT-A dose will range from 50-300 U per arm

A serotype of botulinum toxin type A (BoNT-A) that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction. BoNT-A peripherally applied using optimal parameters by intramuscular injections solely determined by biomechanical analysis of tremulous movements for tremor therapy in both upper extremity every 12 weeks over 42 weeks. BoNT-A dose will range from 50-300 U per arm

Outcomes

Primary Outcome Measures

Kinematic tremor severity
Change from pre to post-BoNT-A treatments in maximum angular tremor amplitude at the wrist in each treated arm. Angular tremor amplitude is one parameter reflecting the vectoral intensity of tremor segmented at each arm joint

Secondary Outcome Measures

Clinical tremor severity
Improvement in upper limb tremor severity as determined by an increase >8 points on a standardized clinical assessment tool (Fahn-Tolosa-Marin Tremor Assessment Scale) pre and post BoNT-A injection using kinematic-determined injection parameters in both ET upper limbs
Accelerometric kinematic tremor severity
Change from pre and post-BoNT-A treatments in maximum log-transformed accelerometric tremor amplitude at wrist level (injected limb). Log-transformed accelerometric tremor amplitude is one parameter reflecting the non-vectoral intensity of tremor.
Quality of life measures
Quality of life for essential tremor questionnaire is used to measure the patient's impression of change due to treatment and its change on their quality of life.

Full Information

First Posted
January 26, 2016
Last Updated
March 9, 2020
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02668497
Brief Title
Kinematic-based BoNT-A Bilateral Upper Limb PD Therapy
Official Title
Kinematic Characterization of Upper Limb Parkinson's Disease Tremor for Optimized Botulinum Toxin Type A Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective is to study the efficacy of botulinum toxin type A (BoNT-A) injected via kinematic parameters in the treatment of unilateral/bilateral upper extremity tremor in Parkinson's disease (PD) tremor. Kinematic assessment tools already developed in past clinical studies will be used in determining injection parameters. The objective is to study the composition of PD tremor using kinematic tools which may contribute to the knowledge of tremor complexity and contribute information that would benefit the development of injection parameters to improve efficacy and optimization of BoNT-A in tremor management. By injecting all bothersome tremulous upper limbs in Parkinson's disease patients, the investigators believe a greater improvement in Quality of Life on more daily tasks can be achieved compared to the investigator's earlier study in unilateral injections (REB#101749), which already showed significant improvement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Movement disorders, Botulinum toxin type A, Tremor, Kinematics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
De-novo PD
Arm Type
Experimental
Arm Description
A serotype of botulinum toxin type A (BoNT-A) that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction. BoNT-A peripherally applied using optimal parameters by intramuscular injections solely determined by biomechanical analysis of tremulous movements for tremor therapy in both upper extremity every 12 weeks over 42 weeks. BoNT-A dose will range from 50-300 U per arm
Arm Title
L-dopa PD
Arm Type
Experimental
Arm Description
A serotype of botulinum toxin type A (BoNT-A) that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction. BoNT-A peripherally applied using optimal parameters by intramuscular injections solely determined by biomechanical analysis of tremulous movements for tremor therapy in both upper extremity every 12 weeks over 42 weeks. BoNT-A dose will range from 50-300 U per arm
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
IncobotulinumtoxinA, BoNT-A
Primary Outcome Measure Information:
Title
Kinematic tremor severity
Description
Change from pre to post-BoNT-A treatments in maximum angular tremor amplitude at the wrist in each treated arm. Angular tremor amplitude is one parameter reflecting the vectoral intensity of tremor segmented at each arm joint
Time Frame
42 weeks
Secondary Outcome Measure Information:
Title
Clinical tremor severity
Description
Improvement in upper limb tremor severity as determined by an increase >8 points on a standardized clinical assessment tool (Fahn-Tolosa-Marin Tremor Assessment Scale) pre and post BoNT-A injection using kinematic-determined injection parameters in both ET upper limbs
Time Frame
42 weeks
Title
Accelerometric kinematic tremor severity
Description
Change from pre and post-BoNT-A treatments in maximum log-transformed accelerometric tremor amplitude at wrist level (injected limb). Log-transformed accelerometric tremor amplitude is one parameter reflecting the non-vectoral intensity of tremor.
Time Frame
42 weeks
Title
Quality of life measures
Description
Quality of life for essential tremor questionnaire is used to measure the patient's impression of change due to treatment and its change on their quality of life.
Time Frame
42 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PD individuals diagnosed by UK Brain Bank Criteria with stage H&Y2-3 disease PD participants who are naïve to PD medications will be grouped into the "De novo" PD group PD participants stable on a low dose of Levodopa or on their PD medications for at least 3 months prior to their study enrolment will be grouped into the "L-dopa" PD group Participants who are botulinum toxin naïve for tremor management Patients will be screened for pregnancy by the physician Individuals with PD will be eligible for the study only if tremor is their primary and most bothersome symptom as determined by clinical exam and patient report denoting tremor-dominant phenotype Participants must be able to provide informed consent and to complete all study assessment scales and tasks. Exclusion Criteria: History of stroke History of ALS or Myasthenia Gravis History of COPD or emphysema Underlying arm muscle weakness or any related compartmental muscle syndrome Offending medications (Lithium, valproate, steroids, amiodarone, beta-adrenergic agonists (e.g. salbutamol). Persons prescribed zonisamide History of allergic or side effect reaction to botulinum toxin Contraindications per the BoNT-A drug monograph Women reporting that they are pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mandar Jog, MD
Organizational Affiliation
LHSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
11472883
Citation
Milanov I. A cross-over clinical and electromyographic assessment of treatment for parkinsonian tremor. Parkinsonism Relat Disord. 2001 Sep;8(1):67-73. doi: 10.1016/s1353-8020(00)00077-8.
Results Reference
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PubMed Identifier
16804646
Citation
Kraus PH, Lemke MR, Reichmann H. Kinetic tremor in Parkinson's disease--an underrated symptom. J Neural Transm (Vienna). 2006 Jul;113(7):845-53. doi: 10.1007/s00702-005-0354-9. Epub 2006 Jan 30.
Results Reference
background
PubMed Identifier
22166467
Citation
Jimenez MC, Vingerhoets FJ. Tremor revisited: treatment of PD tremor. Parkinsonism Relat Disord. 2012 Jan;18 Suppl 1:S93-5. doi: 10.1016/S1353-8020(11)70030-X.
Results Reference
background
PubMed Identifier
25260965
Citation
Imbach LL, Sommerauer M, Leuenberger K, Schreglmann SR, Maier O, Uhl M, Gassert R, Baumann CR. Dopamine-responsive pattern in tremor patients. Parkinsonism Relat Disord. 2014 Nov;20(11):1283-6. doi: 10.1016/j.parkreldis.2014.09.007. Epub 2014 Sep 16.
Results Reference
background
PubMed Identifier
11781398
Citation
Miyasaki JM, Martin W, Suchowersky O, Weiner WJ, Lang AE. Practice parameter: initiation of treatment for Parkinson's disease: an evidence-based review: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2002 Jan 8;58(1):11-7. doi: 10.1212/wnl.58.1.11.
Results Reference
background
PubMed Identifier
19131039
Citation
Nagatsua T, Sawadab M. L-dopa therapy for Parkinson's disease: past, present, and future. Parkinsonism Relat Disord. 2009 Jan;15 Suppl 1:S3-8. doi: 10.1016/S1353-8020(09)70004-5.
Results Reference
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PubMed Identifier
25578445
Citation
Stathis P, Konitsiotis S, Antonini A. Dopamine agonists early monotherapy for the delay of development of levodopa-induced dyskinesias. Expert Rev Neurother. 2015 Feb;15(2):207-13. doi: 10.1586/14737175.2015.1001747. Epub 2015 Jan 12.
Results Reference
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PubMed Identifier
12804486
Citation
Katzenschlager R, Sampaio C, Costa J, Lees A. Anticholinergics for symptomatic management of Parkinson's disease. Cochrane Database Syst Rev. 2003;2002(2):CD003735. doi: 10.1002/14651858.CD003735.
Results Reference
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Kinematic-based BoNT-A Bilateral Upper Limb PD Therapy

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