NCT02418897

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

1.6 years

First QC Date

April 7, 2015

Last Update Submit

November 15, 2016

Conditions

Multiple Sclerosis

Keywords

Fatiguemultiple sclerosisneuromuscular junctionSFEMG

Outcome Measures

Primary Outcomes (1)

  • Number of patients with abnormal Jitter.

    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 Outcomes (1)

  • Score of fatigue (Fatigue severity scale (FSS) and modified fatigue impact scale (MFIS))

    8 months

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients with relapsing remitting multiple sclerosis.
  • Age 18 to 65 years
  • 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.
  • Has a fatigue severity scale score (FSS) of ≥5.
  • Ambulatory with Expanded Disability Status Scale score (EDSS) 1.5 -6.5.
  • Female with no history of multiple sclerosis and no complaint of fatigue
  • Age 18 to 65 years

You may not qualify if:

  • Patients with MS exacerbation or corticosteroid treatment within one month before the study.
  • 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,
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Conditions

Multiple SclerosisFatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed M Eldokla, MD

    Texas Tech University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 16, 2015

Study Start

April 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 16, 2016

Record last verified: 2016-11

Locations

US(1)