Muscle WeaknessNCT02364180
Electromyography in Patients on Chronic Pyridostigmine Therapy
A study testing Electromyography (EMG) in people with Muscle Weakness, run by University of Toledo Health Science Campus at 1 site in United States.
Trial summary
We intend to measure evoked EMG at two sites in subjects who are chronically taking pyridostigmine. Read more about this study
- Who is it for?
- Ages 12 to 90 years
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- Electromyography (EMG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects who have been taking pyridostigmine for the treatment of any condition other than myasthenia gravis
Who cannot join
- Subjects taking pyridostigmine for the treatment of myasthenia gravis will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Toledo, Health Science Campus
Toledo, Ohio, 43614
About this study
Official title: Electromyography With Repetitive Nerve Stimulation in Patients on Chronic Pyridostigmine Therapy
We intend to measure evoked EMG at two sites in subjects who are chronically taking pyridostigmine.
Read the 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.
- Conditions
- Muscle Weakness
- Being tested
- Electromyography (EMG)
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyography (EMG)Diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Electromyography | Other | Subjects taking pyridostigmine bromide for more than 6 weeks for a condition other than myasthenia gravis were observed with Electromyography (EMG) Receives: Diagnostic Test: Electromyography (EMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline measurement only. First and Fifth stimuli delivered 2 seconds apart on the same day. There are no additional days/times.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startDec 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shashi Bhatt, MD, Principal investigator, The University of Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364180
- Sponsor's protocol ID
- Bhatt Pyriodostigmine
- Status last verified
- Mar 2017
- First submitted
- 9 Dec 2014
- Last updated
- 9 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyography With Repetitive Nerve Stimulation in Patients on Chronic Pyridostigmine Therapy
- ClinicalTrials.gov ID
- NCT02364180
- Acronym / sponsor ID
- Bhatt Pyriodostigmine
- Conditions
- Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 16 Feb 2015 (estimated)
- Results
- Posted 31 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Electromyography | Other | Diagnostic Test: Electromyography (EMG)Subjects taking pyridostigmine bromide for more than 6 weeks for a condition other than myasthenia gravis were observed with Electromyography (EMG) |
Who may qualify
- Ages
- 12 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who have been taking pyridostigmine for the treatment of any condition other than myasthenia gravis
Key exclusion criteria (1 listed)
- Subjects taking pyridostigmine for the treatment of myasthenia gravis will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromyography (EMG) | Diagnostic test | Electromyography |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shashi Bhatt, MD principal investigator
The University of Toledo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromyography (EMG) in people with Muscle Weakness, run by University of Toledo Health Science Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.