Role of Neuromuscular Junction Function in Motor Fatigue in Multiple Sclerosis

Completed

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT02418897

Run by

Texas Tech University Health Sciences Center

People needed

40

Starts

2015-04-01

Expected to finish

2016-11-01

Last updated by the study team

2016-11-16

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Inclusion Criteria for MS Group (20 women)
• 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.
• Inclusion Criteria for Control Group (10 women)
• 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,
• radial nerve palsy,
• sleep disorders (Epworth Sleepiness scale> 10 ), or
• significant depression ( Beck's Inventory of Depression Scale >17)
• Taking major fatigue inducing medications. (e.g. Narcotics, and Sedatives)
• Taking anticoagulation therapy. (e.g. warfarin and heparin)

Where it is running

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

Full record on ClinicalTrials.gov

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