Role of Neuromuscular Junction Function in Motor Fatigue in Multiple Sclerosis

November 15, 2016 updated by: Texas Tech University Health Sciences Center

Does Abnormal Neuromuscular Junction Function Play a Role in the Pathogenesis of Motor Fatigue in Women With Multiple Sclerosis?

This pilot study will evaluate for the presence of neuromuscular junction (NMJ) defect in women with motor fatigue in multiple sclerosis by Single Fiber Electromyography (SFEMG) using the concentric needle electrode.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The investigators will recruit 20 women with multiple sclerosis (MS) and fatigue and 10 normal controls with no identified causes of fatigue (no history of thyroid disease, anemia, liver disease, kidney disease, myasthenia gravis, and no major fatigue inducing medications). We will include MS patients with fatigue severity scale of ≥5. Patients with sleep disorders or significant depression will be excluded based on history, Epworth Sleepiness scale, and Beck's Inventory of Depression Scale. The study will include two clinic visits and a one-study visit. After informed consent is obtained (English and Spanish forms will be available), the following will be done during the study visit 1:

  • Neurological examination: Using handgrip dynamometer of the dominant hand.

    • Maximum voluntary isometric contraction force (MVIC) of the handgrip; two contractions of as long as 5 seconds each.
    • Single 30 seconds sustained maximal contraction of the handgrip to assess static fatigue.
    • Series of brief maximal contraction over 30 seconds, Contractions will be timed at one contraction per second.
  • Expanded Disability Status Scale (EDSS
  • Fatigue severity scale (FSS) and modified fatigue impact scale (MFIS)
  • Epworth Sleepiness scale for screening for sleep disorders.
  • Beck's Inventory of Depression Scale for screening for depression. Clinic visit 2: The clinic visit 2 will be conducted 5-30 days after the clinic visit 1

  • Neurological examination: Using handgrip dynamometer of the dominant hand.

    • Maximum voluntary isometric contraction force (MVIC) of the handgrip; two contractions of as long as 5 seconds each.
    • Single 30 seconds sustained maximal contraction of the handgrip to assess static fatigue.
    • Series of brief maximal contraction over 30 seconds, Contractions will be timed at one per second.
  • Fatigue severity scale (FSS) and modified fatigue impact scale (MFIS)

Study Visit 3:

Electromyography (EMG) and SFEMG (Single Fiber Electromyography) of the extensor digitorum communis muscle (forearm muscle) will be performed on all women with fatigue and healthy controls at the TTUHSC electrophysiology lab to evaluate for NMJ abnormalities. The mean consecutive difference (MCD) of 20 pairs of single muscle fiber potentials will be collected using SFEMG from each of the 20 women with multiple sclerosis and fatigue and will be compared to MCD of 200 pair potentials from our recruited 10 normal control subjects and also to the previously published normative data.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Lubbock, Texas, United States, 79430
        • Texas Tech University Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with relapsing remitting multiple sclerosis (MS) with motor fatigue in MS > 6 weeks. Motor fatigue equates to muscle fatigue due to physical exertion and is alleviated with rest and associated with fatigability.

Description

Inclusion Criteria:

Inclusion Criteria for MS Group (20 women)

  1. Patients with relapsing remitting multiple sclerosis.
  2. Age 18 to 65 years
  3. Diagnosed with motor fatigue in multiple sclerosis > 6 weeks. Motor fatigue equates to muscle fatigue due to physical exertion and is alleviated with rest and associated with fatigability.
  4. Has a fatigue severity scale score (FSS) of ≥5.
  5. Ambulatory with Expanded Disability Status Scale score (EDSS) 1.5 -6.5.

Inclusion Criteria for Control Group (10 women)

  1. Female with no history of multiple sclerosis and no complaint of fatigue
  2. Age 18 to 65 years

Exclusion Criteria:

  1. Patients with MS exacerbation or corticosteroid treatment within one month before the study.

  2. Patients with history or current diagnosis of:

    • Untreated thyroid disease,
    • Untreated vitamin D deficiency,
    • pregnancy,
    • taking over the counter energy booster in the last 1 week,
    • taking medication that will improve the function of the neuromuscular junction (i.e. pyridostigmine, steroid, rituximab, mycophenolate mofetil, azathioprine),
    • myasthenia gravis,
    • symptoms or history of polyneuropathy involving the upper extremities,
    • myopathy,
    • symptoms or history suggestive of C7, C 8 radiculopathy,
    • motor neuron disease,
    • polio,
    • chronic inflammatory demyelinating polyneuropathy,
    • Guillain-Barre syndrome,
    • radial nerve palsy,
    • sleep disorders (Epworth Sleepiness scale> 10 ), or
    • significant depression ( Beck's Inventory of Depression Scale >17)
  3. Taking major fatigue inducing medications. (e.g. Narcotics, and Sedatives)
  4. Taking anticoagulation therapy. (e.g. warfarin and heparin)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of patients with abnormal Jitter.
Time Frame: 8 months
Single fiber electromyography (SFEMG) is used to measure the variation between firing of adjacent muscle fibers and to detect prolonged abnormal jitter. The two criteria that the investigator will use to demonstrate abnormal neuromuscular Junction function are the 10% of pairs with abnormal jitter or abnormal mean jitter value of the 20 pairs . The 95% confidence limit of all individual measurements has been used as upper limit of what is considered normal. For extensor digitorum communis (EDC), the 95% confidence limit of jitter in individual pair mean consecutive difference (MCD) is 49 microseconds (MCD of individual pair is 30.6+/-9.2 micros) and the 95% confidence limit of jitter (mean MCD) per study is 38.1 microseconds (MCD per study is 30.7+/-3.7 micros).
8 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Score of fatigue (Fatigue severity scale (FSS) and modified fatigue impact scale (MFIS))
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Tech University Health Sciences Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ahmed M Eldokla, MD, Texas Tech University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • L15-098

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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