Multiple SclerosisNCT02418897
Role of Neuromuscular Junction Function in Motor Fatigue in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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,
Show all 20Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Keywords
- Fatigue, multiple sclerosis, neuromuscular junction, SFEMG
- Medical subject headings
- Multiple Sclerosis, Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 months
Secondary outcomes (1)
Score of fatigue (Fatigue severity scale (FSS) and modified fatigue impact scale (MFIS))
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed M Eldokla, MD, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418897
- Sponsor's protocol ID
- L15-098
- Status last verified
- Nov 2016
- First submitted
- 7 Apr 2015
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Abnormal Neuromuscular Junction Function Play a Role in the Pathogenesis of Motor Fatigue in Women With Multiple Sclerosis?
- ClinicalTrials.gov ID
- NCT02418897
- Acronym / sponsor ID
- L15-098
- Conditions
- Multiple Sclerosis
- Keywords
- Fatigue, multiple sclerosis, neuromuscular junction, SFEMG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- Patients with MS exacerbation or corticosteroid treatment within one month before the study.
- Patients with history or current diagnosis of:
- Taking major fatigue inducing medications. (e.g. Narcotics, and Sedatives)
- Taking anticoagulation therapy. (e.g. warfarin and heparin)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Score of fatigue (Fatigue severity scale (FSS) and modified fatigue impact scale (MFIS))
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
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.
Ahmed M Eldokla, MD principal investigator
Texas Tech University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Texas Tech University Health Sciences Center 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 7 inclusion and 20 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 16 Nov 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with abnormal Jitter. (time frame: 8 months). 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 16 Nov 2016.