Clinical trial NCT02668497: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Movement disorders
Botulinum toxin type A
Tremor
Kinematics
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Kinematic tremor severity
timeFrame: 42 weeks
Secondary outcomes:
measure: Clinical tremor severity
timeFrame: 42 weeks
measure: Accelerometric kinematic tremor severity
timeFrame: 42 weeks
measure: Quality of life measures
timeFrame: 42 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: LHSC
name: Mandar Jog, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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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.
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.
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.