Status:
COMPLETED
Effectiveness of Botox on Reducing Rest Tremor in Parkinson's Disease
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Parkinson Disease
Eligibility:
All Genders
45-80 years
Phase:
PHASE2
Brief Summary
Purpose: Rest tremor in Parkinson's disease is notoriously difficult to treat through pharmacological measures, currently only predictably attenuated by the invasive deep brain stimulation surgery. Th...
Detailed Description
For purposes of properly identifying muscles intended for injection, a portable electromyography will be attached to an appropriate gauge electromyography-guided botulinum toxin needle, which in turn ...
Eligibility Criteria
Inclusion
- At least 45 years of age, and no more than 80 years of age.
- Meet UK Parkinson's disease brain bank diagnostic criteria
- Have clinical evidence of rest tremor of one or both upper extremities defined as involuntary, rhythmic oscillations about any joint within the upper extremities
- Rest tremor amplitude must be at minimum 3 cm as determined by expert opinion by a movement disorders specialist. Confirmation of amplitude measurement will be obtained from the Px1 prior to active participation in the study but will not be used for inclusion/exclusion in study participation.
- Rest tremor must be historically refractory to at least 2 categories of medications typically used as anti-parkinsonian agents including levodopa formulations, dopamine agonists, amantadine, and anticholinergics.
- Participants must be able to make no changes to their anti-parkinsonian medications for 150 days (study duration). Ability and safety to do so must also be determined by the participant's treating physician and confirmed in writing prior to participating.
- Able to provide informed consent
Exclusion
- History of having undergone botulinum toxin injections for any other condition previously
- Allergy to carbidopa or levodopa.
- Prescreening Montreal Cognitive Assessment (MoCA) score less than 22
- Prescreening muscle weakness as determined by Medical Research Council grade less than 5/5 on direct testing in the upper limb afflicted with rest tremor.
- Pregnancy: documentation of non-pregnancy by urine pregnancy test will be obtained from all women of child-bearing potential prior to participation
- Infection at the proposed injection site
- Those with a pre-existing, concomitant neuromuscular disorder
- Compromised respiratory function
- History of having undergone deep brain stimulation surgery for any condition
Key Trial Info
Start Date :
March 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03301272
Start Date
March 22 2018
End Date
August 21 2019
Last Update
August 17 2020
Active Locations (1)
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1
UNC Hospitals Neurology Clinic
Chapel Hill, North Carolina, United States, 27517