Kinematic-based BoNT-A Bilateral Upper Limb PD Therapy

Parkinson's Disease Clinical Trial

Official title:

Kinematic Characterization of Upper Limb Parkinson's Disease Tremor for Optimized Botulinum Toxin Type A Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02668497
• Other study ID #: 107433
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Botulinum Toxin Type A

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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. — View Citation

Jiménez 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. Review. — View Citation

Katzenschlager R, Sampaio C, Costa J, Lees A. Anticholinergics for symptomatic management of Parkinson's disease. Cochrane Database Syst Rev. 2003;(2):CD003735. Review. — View 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. Epub 2006 Jan 30. — View Citation

Milanov I. A cross-over clinical and electromyographic assessment of treatment for parkinsonian tremor. Parkinsonism Relat Disord. 2001 Sep;8(1):67-73. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	42 weeks
Secondary	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	42 weeks
Secondary	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.	42 weeks
Secondary	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.	42 weeks