Electromyography in Patients on Chronic Pyridostigmine Therapy

NCT02364180 | Completed Results

• 1 other identifier: Bhatt Pyriodostigmine
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Muscle Weakness

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Electromyography

OTHER

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)

Interventions

Electromyography (EMG) DIAGNOSTIC_TEST

Electromyography

Eligibility Criteria

• Age: 12 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Toledo Health Science Campus: lead

Study Sites (1)

University of Toledo, Health Science Campus

Toledo, Ohio, 43614, United States

Location

MeSH Terms

Conditions

Muscle Weakness

Interventions

Electromyography

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography

Results Point of Contact

• Title: Shashi Bhatt, MD
• Organization: The University of Toledo

Shashi.Bhatt@utoledo.edu

419-383-3556

Study Officials

• Shashi Bhatt, MD

  The University of Toledo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: February 16, 2015
• Study Start: December 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 9, 2017
• Results First Posted: March 31, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)