Kinematic-based BoNT-A Injections for Bilateral ET
Primary Purpose
Essential Tremor
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Botulinum toxin type A
Sponsored by
About this trial
This is an interventional treatment trial for Essential Tremor focused on measuring Movement disorders, Botulinum toxin type A, Kinematics
Eligibility Criteria
Inclusion Criteria:
- Consenting male and female participants
- Diagnosis of 'definite essential tremor' in accordance with the TRIG criteria including: ET individuals diagnosed with upper limb tremor in their motor dominant and non-dominant hands
- Stable ET medication management for the 3 month duration prior to their enrollment in the study
- Participants who are botulinum toxin naïve for tremor management
- Patients will be screened for pregnancy by the physician
Exclusion Criteria:
- History of stroke
- Muscle weakness or any related compartmental muscle syndrome
- Smoking
- History of ALS or Myasthenia Gravis
- 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 Xeomin® drug monograph
- Women reporting that they are pregnant
Sites / Locations
- London Health Sciences Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Essential tremor treatment
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. Participants will be treated by BoNT-A injections every 12 weeks over 72 weeks. BoNT-A parameters will be determined solely by biomechanical analysis of tremulous movements in both upper extremity 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 Xeomin® 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
NCT ID
NCT02551848
First Posted
September 11, 2015
Last Updated
June 18, 2020
Sponsor
Western University, Canada
1. Study Identification
Unique Protocol Identification Number
NCT02551848
Brief Title
Kinematic-based BoNT-A Injections for Bilateral ET
Official Title
Botulinum Toxin Type A for Injection of Bilateral Upper Extremity Tremor in Patients With Essential Tremor Using Kinematic Assessment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
December 2021 (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 (Xeomin®) injected utilizing kinematically-based injection parameters for the treatment of upper extremity essential tremor (ET). Additional objectives are to study the benefit of kinematic assessment tools in determining injection parameters and to study the composition of tremor using kinematics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
Movement disorders, Botulinum toxin type A, Kinematics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Essential tremor treatment
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.
Participants will be treated by BoNT-A injections every 12 weeks over 72 weeks. BoNT-A parameters will be determined solely by biomechanical analysis of tremulous movements in both upper extremity 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, Xeomin
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
72 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 Xeomin® injection using kinematic-determined injection parameters in both ET upper limbs
Time Frame
72 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
72 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
72 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:
Consenting male and female participants
Diagnosis of 'definite essential tremor' in accordance with the TRIG criteria including: ET individuals diagnosed with upper limb tremor in their motor dominant and non-dominant hands
Stable ET medication management for the 3 month duration prior to their enrollment in the study
Participants who are botulinum toxin naïve for tremor management
Patients will be screened for pregnancy by the physician
Exclusion Criteria:
History of stroke
Muscle weakness or any related compartmental muscle syndrome
Smoking
History of ALS or Myasthenia Gravis
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 Xeomin® 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
1579114
Citation
Schantz EJ, Johnson EA. Properties and use of botulinum toxin and other microbial neurotoxins in medicine. Microbiol Rev. 1992 Mar;56(1):80-99. doi: 10.1128/mr.56.1.80-99.1992.
Results Reference
background
PubMed Identifier
20567945
Citation
Evidente VG, Adler CH. An update on the neurologic applications of botulinum toxins. Curr Neurol Neurosci Rep. 2010 Sep;10(5):338-44. doi: 10.1007/s11910-010-0129-z.
Results Reference
background
PubMed Identifier
17117170
Citation
Benito-Leon J, Louis ED. Essential tremor: emerging views of a common disorder. Nat Clin Pract Neurol. 2006 Dec;2(12):666-78; quiz 2p following 691. doi: 10.1038/ncpneuro0347.
Results Reference
background
PubMed Identifier
21179530
Citation
Gironell A, Kulisevsky J. Diagnosis and management of essential tremor and dystonic tremor. Ther Adv Neurol Disord. 2009 Jul;2(4):215-22. doi: 10.1177/1756285609104791.
Results Reference
background
PubMed Identifier
8723140
Citation
Jankovic J, Schwartz K, Clemence W, Aswad A, Mordaunt J. A randomized, double-blind, placebo-controlled study to evaluate botulinum toxin type A in essential hand tremor. Mov Disord. 1996 May;11(3):250-6. doi: 10.1002/mds.870110306.
Results Reference
background
PubMed Identifier
11402109
Citation
Brin MF, Lyons KE, Doucette J, Adler CH, Caviness JN, Comella CL, Dubinsky RM, Friedman JH, Manyam BV, Matsumoto JY, Pullman SL, Rajput AH, Sethi KD, Tanner C, Koller WC. A randomized, double masked, controlled trial of botulinum toxin type A in essential hand tremor. Neurology. 2001 Jun 12;56(11):1523-8. doi: 10.1212/wnl.56.11.1523.
Results Reference
background
PubMed Identifier
15364688
Citation
Adler CH, Bansberg SF, Hentz JG, Ramig LO, Buder EH, Witt K, Edwards BW, Krein-Jones K, Caviness JN. Botulinum toxin type A for treating voice tremor. Arch Neurol. 2004 Sep;61(9):1416-20. doi: 10.1001/archneur.61.9.1416.
Results Reference
background
PubMed Identifier
15972843
Citation
Zesiewicz TA, Elble R, Louis ED, Hauser RA, Sullivan KL, Dewey RB Jr, Ondo WG, Gronseth GS, Weiner WJ; Quality Standards Subcommittee of the American Academy of Neurology. Practice parameter: therapies for essential tremor: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2005 Jun 28;64(12):2008-20. doi: 10.1212/01.WNL.0000163769.28552.CD. Epub 2005 Jun 22.
Results Reference
background
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Kinematic-based BoNT-A Injections for Bilateral ET
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