Effectiveness of Botox on Reducing Rest Tremor in Parkinson's Disease
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 45 - 80 |
| Updated: | 2/21/2019 |
| Start Date: | March 22, 2018 |
| End Date: | August 2019 |
Effectiveness of Onabotulinumtoxin A on Reduction of Rest Tremor in Parkinson's Disease: a Pilot Study
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. We hope to find some predictable and clinically meaningful attenuation
of tremor with targeted use of onabotulinum toxin on muscles involved in creating the tremor.
Participants: 16 subjects who meet UK brain bank criteria for Parkinson's disease with
medically refractory rest tremor of at least 3 cm amplitude.
Procedures (methods): Subjects will be blinded to receive either sham saline injection versus
onabotulinum toxin injections directed to muscle groups felt to be clinically involved in
causing the oscillatory movement of the tremor. Assessment of tremor severity and functional
improvement from baseline after injection will occur within group (i.e. each subject will
serve as their own control).
Hypotheses:
1. (A) Onabotulinumtoxin A significantly attenuates the amplitude of medically-refractory
rest tremor of the upper limb in Parkinson's patients as compared to sham injections; as
measured by reduction in the MDS-UPDRS tremor subscore.
1. (B) Onabotulinumtoxin A significantly improves the limb function of Parkinson's patients
with medically-refractory rest tremor of the upper limb as compared to sham injections; as
measured by an increase in ARAT scores.
pharmacological measures, currently only predictably attenuated by the invasive deep brain
stimulation surgery. We hope to find some predictable and clinically meaningful attenuation
of tremor with targeted use of onabotulinum toxin on muscles involved in creating the tremor.
Participants: 16 subjects who meet UK brain bank criteria for Parkinson's disease with
medically refractory rest tremor of at least 3 cm amplitude.
Procedures (methods): Subjects will be blinded to receive either sham saline injection versus
onabotulinum toxin injections directed to muscle groups felt to be clinically involved in
causing the oscillatory movement of the tremor. Assessment of tremor severity and functional
improvement from baseline after injection will occur within group (i.e. each subject will
serve as their own control).
Hypotheses:
1. (A) Onabotulinumtoxin A significantly attenuates the amplitude of medically-refractory
rest tremor of the upper limb in Parkinson's patients as compared to sham injections; as
measured by reduction in the MDS-UPDRS tremor subscore.
1. (B) Onabotulinumtoxin A significantly improves the limb function of Parkinson's patients
with medically-refractory rest tremor of the upper limb as compared to sham injections; as
measured by an increase in ARAT scores.
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 will be used to hear/see motor evoked potentials (MEPs). Subjects
will be asked to activate the muscle while needle is inserted to ensure proper placement of
the needle in the desired muscle prior to injection of study solution.
electromyography will be attached to an appropriate gauge electromyography-guided botulinum
toxin needle, which in turn will be used to hear/see motor evoked potentials (MEPs). Subjects
will be asked to activate the muscle while needle is inserted to ensure proper placement of
the needle in the desired muscle prior to injection of study solution.
Inclusion Criteria:
1. At least 45 years of age, and no more than 80 years of age.
2. Meet UK Parkinson's disease brain bank diagnostic criteria
3. Have clinical evidence of rest tremor of one or both upper extremities defined as
involuntary, rhythmic oscillations about any joint within the upper extremities
4. 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.
5. 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.
6. 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.
7. Able to provide informed consent
Exclusion Criteria:
1. History of having undergone botulinum toxin injections for any other condition
previously
2. Allergy to carbidopa or levodopa.
3. Prescreening Montreal Cognitive Assessment (MoCA) score less than 22
4. 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.
5. Pregnancy: documentation of non-pregnancy by urine pregnancy test will be obtained
from all women of child-bearing potential prior to participation
6. Infection at the proposed injection site
7. Those with a pre-existing, concomitant neuromuscular disorder
8. Compromised respiratory function
9. History of having undergone deep brain stimulation surgery for any condition
We found this trial at
1
site
194 Finley Golf Course Road
Chapel Hill, North Carolina 27517
Chapel Hill, North Carolina 27517
Principal Investigator: Daniel A Roque, MD
Phone: 984-974-2266
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