Kinematic-based BoNT-A Injections for Bilateral ET
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|ClinicalTrials.gov Identifier: NCT02551848|
Recruitment Status : Active, not recruiting
First Posted : September 16, 2015
Last Update Posted : April 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Essential Tremor||Drug: Botulinum toxin type A||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Botulinum Toxin Type A for Injection of Bilateral Upper Extremity Tremor in Patients With Essential Tremor Using Kinematic Assessment|
|Actual Study Start Date :||August 2014|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||December 2021|
Experimental: Essential tremor treatment
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
Drug: Botulinum toxin type A
- Kinematic tremor severity [ Time Frame: 72 weeks ]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
- Clinical tremor severity [ Time Frame: 72 weeks ]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 [ Time Frame: 72 weeks ]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 [ Time Frame: 72 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551848
|London Health Sciences Centre|
|London, Ontario, Canada, N6A5A5|
|Principal Investigator:||Mandar Jog, MD||LHSC|