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Electromyography in Patients on Chronic Pyridostigmine Therapy

Primary Purpose

Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electromyography (EMG)
Sponsored by
University of Toledo Health Science Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Muscle Weakness

Eligibility Criteria

12 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Toledo, Health Science Campus

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Electromyography

Arm Description

Subjects taking pyridostigmine bromide for more than 6 weeks for a condition other than myasthenia gravis were observed with Electromyography (EMG)

Outcomes

Primary Outcome Measures

Percent Change in the Amplitude of Evoked Compound Muscle Action Potential by Electromyography Between the First to Fifth Response
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.

Secondary Outcome Measures

Full Information

First Posted
December 9, 2014
Last Updated
March 31, 2017
Sponsor
University of Toledo Health Science Campus
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1. Study Identification

Unique Protocol Identification Number
NCT02364180
Brief Title
Electromyography in Patients on Chronic Pyridostigmine Therapy
Official Title
Electromyography With Repetitive Nerve Stimulation in Patients on Chronic Pyridostigmine Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Toledo Health Science Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
We intend to measure evoked EMG at two sites in subjects who are chronically taking pyridostigmine.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electromyography
Arm Type
Other
Arm Description
Subjects taking pyridostigmine bromide for more than 6 weeks for a condition other than myasthenia gravis were observed with Electromyography (EMG)
Intervention Type
Diagnostic Test
Intervention Name(s)
Electromyography (EMG)
Primary Outcome Measure Information:
Title
Percent Change in the Amplitude of Evoked Compound Muscle Action Potential by Electromyography Between the First to Fifth Response
Description
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.
Time Frame
Baseline measurement only. First and Fifth stimuli delivered 2 seconds apart on the same day. There are no additional days/times.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shashi Bhatt, MD
Organizational Affiliation
The University of Toledo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toledo, Health Science Campus
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Electromyography in Patients on Chronic Pyridostigmine Therapy

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