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We intend to measure evoked EMG at two sites in subjects who are chronically taking pyridostigmine.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electromyography | Other | Subjects taking pyridostigmine bromide for more than 6 weeks for a condition other than myasthenia gravis were observed with Electromyography (EMG) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electromyography (EMG) | Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline measurement only. First and Fifth stimuli delivered 2 seconds apart on the same day. There are no additional days/times. |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Shashi Bhatt, MD | The University of Toledo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Toledo, Health Science Campus | Toledo | Ohio | 43614 | United States |
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All subjects taking Pyridostigmine for at least 6months, except for the treatment of myasthenia gravis, will be considered. Subjects will be recruited from existing patients treated at the university and will be seen in the outpatient clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pyridostigmine Bromide Treatment Group | pyridostigmine bromide treatment is a single arm. Subjects must be treated with pyridostigmine for at least 6months and must not be treated for myasthenia gravis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pyridostigmine Bromide Treatment Group | All subjects investigated were taking pyridostigmine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Full Range | percent change | Baseline measurement only. First and Fifth stimuli delivered 2 seconds apart on the same day. There are no additional days/times. |
|
There were no adverse events to collect during the time of the subject participation which was 1 day.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pyridostigmine Bromide Treatment Group | In all enrolled subjects (10), who were known pyridostigmine bromide pts that were observed with Electromyography (EMG), there were no adverse events anticipated. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shashi Bhatt, MD | The University of Toledo | 419-383-3556 | Shashi.Bhatt@utoledo.edu |
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| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D004576 | Electromyography |
| ID | Term |
|---|---|
| D004568 | Electrodiagnosis |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009213 | Myography |
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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.
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |