Status:
COMPLETED
Assessment of the Effect of Botulinum Toxin in Extensor Digitorum Brevis Via Strain Gauge and Nerve Conduction Studies
Lead Sponsor:
Loma Linda University
Collaborating Sponsors:
Allergan
Conditions:
Muscle Strength
Botulinum Toxins, Type A
Eligibility:
All Genders
18-54 years
Phase:
NA
Brief Summary
The purpose of this feasibility study is to determine if temporary weakness of a small foot muscle caused by local injection of botulinum toxin into that muscle can be measured with a strain gauge in ...
Detailed Description
Purpose/Hypothesis: Verify the validity and reliability of strain gauge assessment of strength of extensor digitorum brevis (EDB) muscle compared to compound muscle action potential (CMAP) size from ...
Eligibility Criteria
Inclusion
- Normal, healthy, male or female subjects, 18 to 54 years of age.
- Written informed consent has been obtained.
- Females with child-bearing potential have a negative urine pregnancy test and agree to use a reliable form of contraception during the study.
- Ability to follow study instructions and likely to complete all required visits.
- Written authorization for Use and Release of Health and Research Study Information has been obtained.
Exclusion
- Abnormality by focused history and examination including the presence of foot deformity.
- Abnormal (as determined by the investigator) screening nerve conduction studies of the lower limbs.
- Identification of anomalous innervation of right EDB via screening nerve conduction studies.
- The subject having a foot which does not adequately fit in the modified ankle-foot orthosis used with the strain gauge.
- The subject having a foot in which anatomic bone landmarks cannot be adequately identified.
- Body mass index (BMI) greater than 30.
- History of significant (as determined by the investigator) lower limb injury or lower limb surgery
- Any uncontrolled clinically significant medical condition.
- Known allergy or sensitivity to any of the components in the study medication.
- Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
- Concurrent participation in another investigational drug or device study or participation within 3 months prior to study.
- Treatment with botulinum toxin of any serotype prior to enrollment in study or prior clinical botulism.
- Any medical condition that may put the subject at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Lambert-Eaton myasthenic syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function.
- Evidence of alcohol abuse, drug abuse, or other relevant neuropsychiatric condition.
- Infection or skin disorder at an anticipated injection site.
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results (e.g. variable strength on serial testing during screening examination; or foot, toe, or ankle pain that may limit full participation in muscle strength testing), or interfere significantly with the subject's participation in the study.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00822523
Start Date
January 1 2009
End Date
July 1 2015
Last Update
September 5 2018
Active Locations (2)
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1
Electromyography Laboratory, Loma Linda University Medical Center
Loma Linda, California, United States, 92354
2
Loma Linda University
Loma Linda, California, United States, 92354