Electromyography in Patients on Chronic Pyridostigmine Therapy

Muscle Weakness Clinical Trial

Official title:

Electromyography With Repetitive Nerve Stimulation in Patients on Chronic Pyridostigmine Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02364180
• Other study ID #: Bhatt Pyriodostigmine
• Status: Recruiting
• Phase: Phase 3
• First received: December 9, 2014
• Last updated: February 2, 2016
• Start date: December 2013
• Est. completion date: February 2017

Study information

• Verified date: February 2016
• Source: University of Toledo Health Science Campus
• Contact: Denise Zeller, RN
• Phone: 419-383-6223
• Email: denise.zeller[@]utoledo.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The investigators are intending to enroll Patients who are chronically treated with pyridostigmine for the treatment of any medical condition and presenting at the investigators' outpatient clinics for follow up appointment. Subjects taking pyridostigmine for the treatment of myasthenia gravis will be excluded. Both adults and children older than 12 years of age will be approached. Those subjects that agree to participate will be asked to sign an informed consent. For the participation of minors a parental (or guardian) consent and subject assent will be obtained. Those that participate will answer a few questions pertaining to their medical history and will then undergo electromyograph (CMAP) measurement with repetitive stimulation at 2 sites (ulnar nerve at the wrist and the accessory nerve in the neck). Evoked electromyogram will be recorded on a computer hard drive. Eight percent or greater decrement in the CMAP response on repetitive stimulation will be considered positive.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subjects who have been taking pyridostigmine for the treatment of any condition

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis

Locations

Country	Name	City	State
United States	University of Toledo, Health Science Campus	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Toledo Health Science Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fade of Compound Muscle Action Potential on repetitive nerve stimulation	Normally when a nerve is rapidly stimulated the successive Compound Muscle Action Potentials (CMAP) are of the same height. We are hoping to investigate if chronic pyridostimine therapy reduces the margin of safety and hence the successive CMAPs may be smaller than the preceding ones.	Baseline	No