NCT00004553

Brief Summary

This study will investigate problems with muscle weakness and control using electromyography-a test of nerve-muscle cell communication. Advanced techniques called single fiber electromyography and macro-electromyography, which evaluate individual muscle fibers, will be used. Besides aiding in diagnosis, these tests provide information about disease progression that may be useful in guiding therapy. Adult patients with suspected neurological disorders of muscle control and weakness may be eligible for this study. Normal volunteers may also participate. For the electromyography procedure, a special needle is inserted into a muscle. The patient will slightly tense the muscle and maintain the tension while electrical signals from the muscle fibers are being recorded. The electrical signals are played through a loudspeaker, providing feedback to help the patient tense the muscle the appropriate amount. The test, which is usually done for only one muscle, takes 1 to 2 hours. If needed, short breaks can be taken. If the patient cannot maintain tension in the muscle for the entire test period, a nerve will be stimulated to activate the muscle. A thin needle is inserted near the nerve, and a series of small electrical shocks are given to activate a nerve fiber. The electromyography needle is inserted into the muscle to measure the response, as described above. A neurologist receiving specialized training in clinical neurophysiology will do the electromyography procedure under the direct supervision of an experienced neurologist.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Feb 2000

Longer than P75 for not_applicable healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 7, 2000

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

November 1, 2005

First QC Date

February 4, 2000

Last Update Submit

March 3, 2008

Conditions

Keywords

Single Fiber EMGMacro-EMGMyastheniaPost-Polio SyndromeNeuromuscular TransmissionMotor DysfunctionNeuromuscular Disorder

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with weakness or motor dysfunction: 8/year.
  • Normal volunteers, adults: 2/year.

You may not qualify if:

  • Anticoagulation or uncorrected bleeding disorder.
  • Children are not optimal subjects for fellows undergoing training in these techniques and will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • Sanders DB, Stalberg EV. AAEM minimonograph #25: single-fiber electromyography. Muscle Nerve. 1996 Sep;19(9):1069-83. doi: 10.1002/(SICI)1097-4598(199609)19:93.0.CO;2-Y.

    PMID: 8761262BACKGROUND
  • Grimby G, Stalberg E, Sandberg A, Sunnerhagen KS. An 8-year longitudinal study of muscle strength, muscle fiber size, and dynamic electromyogram in individuals with late polio. Muscle Nerve. 1998 Nov;21(11):1428-37. doi: 10.1002/(sici)1097-4598(199811)21:113.0.co;2-x.

    PMID: 9771666BACKGROUND

MeSH Terms

Conditions

Neuromuscular DiseasesPostpoliomyelitis SyndromeNeurologic Manifestations

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Nervous System DiseasesPoliomyelitisMyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesCentral Nervous System DiseasesSpinal Cord DiseasesNeurodegenerative DiseasesNeuroinflammatory DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
NIH

Study Record Dates

First Submitted

February 4, 2000

First Posted

February 7, 2000

Study Start

February 1, 2000

Study Completion

November 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-11

Locations