Multiple Sclerosis Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
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) |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Texas Tech University Health Sciences Center | Lubbock | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Tech University Health Sciences Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Score of fatigue (Fatigue severity scale (FSS) and modified fatigue impact scale (MFIS)) | 8 months | No |
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