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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Toledo Health Science Campus
ClinicalTrials.gov Identifier:
NCT02364180
First received: December 9, 2014
Last updated: March 31, 2017
Last verified: March 2017
  Purpose
We intend to measure evoked EMG at two sites in subjects who are chronically taking pyridostigmine.

Condition Intervention
Muscle Weakness Diagnostic Test: Electromyography (EMG)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
All subjects taking Pyridostigmine for at least 6mo, except for myasthenia gravis patients, will be considered for the study.Those that participate will answer a few questions pertaining to their medical history and will then undergo electromyography (CMAP) measurement with repetitive stimulation at 2 sites (ulnar nerve at the wrist and the accessory nerve in the neck). The first and fifth stimuli are delivered 2 seconds apart. Eight percent or greater decrement in the CMAP response on repetitive stimulation will be considered positive.
Masking: No masking
Primary Purpose: Supportive Care
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:
  • Percent Change in the Amplitude of Evoked Compound Muscle Action Potential by Electromyography Between the First to Fifth Response [ Time Frame: Baseline measurement only. First and Fifth stimuli delivered 2 seconds apart on the same day. There are no additional days/times. ]
    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 pyridostigmine therapy reduces the margin of safety and hence the successive CMAPs may be smaller than the preceding ones.


Enrollment: 11
Study Start Date: December 2013
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Electromyography
Subjects taking pyridostigmine bromide for more than 6 weeks for a condition other than myasthenia gravis were observed with Electromyography (EMG)
Diagnostic Test: Electromyography (EMG)

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   12 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have been taking pyridostigmine for the treatment of any condition other than myasthenia gravis

Exclusion Criteria

  • Subjects taking pyridostigmine for the treatment of myasthenia gravis will be excluded.
  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

Locations
United States, Ohio
University of Toledo, Health Science Campus
Toledo, Ohio, United States, 43614
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
Results First Received: November 21, 2016
Last Updated: March 31, 2017
Individual Participant Data  
Plan to Share IPD: No

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 June 23, 2017