NCT00822523

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

Strain Gauge Feasibility Assessment & Correlation With Compound Muscle Action Potential & Surface Electromyogram Parameters Before & After a Single Intramuscular Injection of Botulinum Toxin Type A Into Extensor Digitorum Brevis Muscle

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

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

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 EDB and surface electromyography (SEMG) data from EDB after injection of botulinum toxin into EDB 1. Primary Outcome Measure: Change in measured strength (using strain gauges) of dorsiflexion of digits 3 and 4 ("strength of EDB") after vs. before botulinum toxin injection into EDB 2. Secondary Outcome Measures: 1. Change in CMAP (with standard reference electrode location and with an "inactive" reference electrode location) from EDB after vs. before botulinum toxin injection into EDB; 2. Change in SEMG parameters from EDB, tibialis anterior (TA), and extensor digitorum longus (EDL) after vs. before botulinum toxin injection into EDB STUDY DESIGN: 1. Overview: Single intramuscular injection of botulinum toxin or placebo (placebo or BOTOX 2 units or BOTOX 20 units, each with a total volume of 0.1 ml) intramuscular into right EDB on Day 0. Strain gauge data and SEMG data from TA and EDL are obtained at each evaluation time: Baseline (3 separate times prior to Day 0 after at least 5 separate training sessions for the strain gauges); Day 1; Day 2; Day 4 (during anticipated rapid change); Day 14 (+/-1 day) (at clinical nadir); Day 21 (+/-1 day) (another day at clinical nadir); and Month 4 (when clinical recovery from the effect of BOTOX should have occurred); CMAP \& SEMG data from EDB are obtained at Baseline; Day 4 (close to nadir of CAMP); Day 14 (at nadir of CAMP) and/or Day 21 (at nadir of CAMP); and Month 4 (when clinical recovery from the effect of BOTOX should have occurred but CMAP should not have recovered). 2. Protocol: Single-center, Double-Blind, Randomized, Pilot Trial Total Sample Size: 12-15 Treatment Groups: BOTOX Single Dose 20 units IM in EDB in 0.1 ml BOTOX Single Dose 2 units IM in EDB in 0.1 ml Placebo (Saline) Single Dose IM in EDB in 0.1 ml Estimated Time to Enroll: 0-3 months Estimated Study Duration: 4-6 months

Conditions

• Muscle Strength
• Botulinum Toxins, Type A

Interventions

Type	Name	Description
DRUG	Botulinum Toxin, Type A	20 units, single dose, intramuscular in right EDB muscle
DRUG	Botulinum Toxin, Type A	2 units, single dose, intramuscular to right EDB muscle
DRUG	Saline	Single Dose, Intramuscular into right EDB muscle

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-03-01
• Completion: 2015-07-01
• First posted: 2009-01-14
• Last updated: 2018-09-05
• Results posted: 2016-08-31

Locations

2 sites across 1 country: United States