Assessment of the Effect of Botulinum Toxin in Extensor Digitorum Brevis Via Strain Gauge and Nerve Conduction Studies

Completed · Not applicable · Has a placebo group

Conditions studied: Muscle Strength, Botulinum Toxins, Type A

In brief

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 addition to the previously known valid measurements via nerve conduction studies and surface electromyogram.

Key facts

Study ID

NCT00822523

Run by

Loma Linda University

People needed

13

Starts

2009-01-01

Expected to finish

2015-07-01

Last updated by the study team

2018-09-05

Who can join

Age: 18 and older, up to 54. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Electromyography Laboratory, Loma Linda University Medical Center — Loma Linda, California, United States
• Loma Linda University — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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