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Trial record 1 of 1 for:    Electromyography in Patients on chronic Pyridostigmine Therapy
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Electromyography in Patients on Chronic Pyridostigmine Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by University of Toledo Health Science Campus
Sponsor:
Information provided by (Responsible Party):
University of Toledo Health Science Campus
ClinicalTrials.gov Identifier:
NCT02364180
First received: December 9, 2014
Last updated: February 2, 2016
Last verified: February 2016
  Purpose
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.

Condition Phase
Muscle Weakness
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electromyography With Repetitive Nerve Stimulation in Patients on Chronic Pyridostigmine Therapy

Resource links provided by NLM:


Further study details as provided by University of Toledo Health Science Campus:

Primary Outcome Measures:
  • Fade of Compound Muscle Action Potential on repetitive nerve stimulation [ Time Frame: Baseline ]
    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.


Estimated Enrollment: 50
Study Start Date: December 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
pyridostigmine bromide treatment group
Subjects taking pyridostigmine bromide for more than 6 weeks for a condition other than myasthenia gravis

  Eligibility

Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have been taking pyridostigmine for the treatment of any condition.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02364180

Contacts
Contact: Denise Zeller, RN 419-383-6223 denise.zeller@utoledo.edu
Contact: Eisenhauer Christina, RN 419-383-6784 christina.eisenhauer@utoledo.edu

Locations
United States, Ohio
University of Toledo, Health Science Campus Recruiting
Toledo, Ohio, United States, 43614
Contact: Shashi Bhatt, MD    419-383-3556    shashi.bhatt@utoledo.edu   
Principal Investigator: Shashi Bhatt, MD         
Sponsors and Collaborators
University of Toledo Health Science Campus
Investigators
Principal Investigator: Shashi Bhatt, MD The University of Toledo
  More Information

Responsible Party: University of Toledo Health Science Campus
ClinicalTrials.gov Identifier: NCT02364180     History of Changes
Other Study ID Numbers: Bhatt Pyriodostigmine 
Study First Received: December 9, 2014
Last Updated: February 2, 2016

Additional relevant MeSH terms:
Pyridostigmine Bromide
Muscle Weakness
Paresis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 20, 2017