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Completed

NCT Number: NCT01182558

The Effect of Prior Muscle Activation on the Compound Muscle Action Potential (CMAP)

The purpose of this investigator-initiated study is to determine the effect of prior muscle activation on the response obtained by nerve conduction studies (the compound muscle action potential [CMAP]) looking at the amplitude, area, and duration of the CMAP and evaluating the length of time the CMAP is larger than at baseline. On the opposite side, the corresponding CMAP will be tested periodically, but there will be no muscle activation on that side.

Null Hypothesis: While controlling all possible technical and other known physiological variables, prior activation of a muscle has no effect on the amplitude and area of the compound muscle action potential (CMAP); and the CMAP does not change over time in the relaxed muscle (on the opposite side).

The investigators suspect that there is an effect of prior activation of the muscle on the subsequent CMAP recorded from that muscle.

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurology - Faculty Physicians and Surgeons of Loma Linda University School of Medicine

Loma Linda, California, 92354, United States

About this study

Nerve conduction studies (NCS) will be performed with supramaximal nerve stimulation, surface stimulation, surface recording, and with best possible technique controlling as many variables as possible including the location of the recording electrodes and with a warm muscle and nerve (measuring temperature at the skin) in each of 3 "arms" of the study:

  • ulnar nerve stimulation at the wrist recording from the hypothenar eminence,
  • median nerve stimulation at the wrist recording from the thenar eminence, and
  • peroneal nerve stimulation at the ankle recording from the extensor digitorum brevis muscle.

NCS will be performed in a rested muscle (rested for 15 minutes or longer) and then multiple times for up to 40 minutes after maximum isometric contraction (activation) of the tested muscle for a defined length of time. The defined lengths of muscle activation include:

  • "a brief twitch" (activation for a fraction of a second),
  • 2 seconds,
  • 5 seconds,
  • 10 seconds, and
  • 20 seconds (two epochs of 10 seconds of activation with 1-2 seconds of rest between the two epochs).

The CMAP will be recorded multiple times from the muscle which was activated (pre-activation; as well as post-activation at multiple times after muscle activation: immediately, 5 sec, 10 sec, 15 sec, 20 sec, 30 sec, 60 sec, 90 sec, 2 minutes, and every minute up to as long as 40 minutes). Similar recordings will be made after each of the 5 durations of muscle activation ("a brief twitch," 2 seconds, 5 seconds, 10 seconds, and 20 seconds) of each of the three muscles (hypothenar, thenar, and EDB). CMAP amplitude (baseline to negative peak), area (under the negative curve), and duration (of the negative CMAP) will each be measured at each timepoint; and skin temperature in the region of the "active" recording electrode will be measured. Each data type will be compared over time in a series, identified as muscle from which recorded, duration of muscle activation performed prior to the recording, and time after the end of muscle activation.

On a few occasions during the testing of the CMAP on the side on which the muscle is activated, there will be recording of the CMAP from the corresponding muscle on the opposite side, but that second side will be relaxed the entire time of testing (for 4-5 hours).

If the CMAP changes more than a small amount on either side, F waves may be tested while the muscle is at rest.

Each subject will participate in each of the 3 "arms." Testing for the five series of recordings from each muscle is anticipated to take 4-5 hours, i.e., after screening, 12-15 hours total for testing the 3 muscles in each subject.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normal, healthy volunteers
  • Age 18-49

Exclusion criteria

  • Localized or generalized neuromuscular disorder
  • History of neuropathy
  • History of diabetes
  • History of prior injuries or surgeries of the back, neck, or limbs to be tested which in the opinion of the investigator might have the potential to influence the compound muscle action potential
  • Medications other than eyedrops or non-steroidal anti-inflammatory agents (as needed) or contraceptive agents or non-steroidal topical agents
  • Abnormalities by screening nerve conduction studies
  • Anomalous innervation of the tested extensor digitorum brevis via screening nerve conduction studies
  • Use of caffeine or nicotine within 8 hours of testing

Treatment and study plan

Hypothenar muscle activation--maximum, voluntary, isometric

Other

Each subject will perform maximum, voluntary, isometric muscle activation (of the target muscle) for each of various durations ("single brief muscle twitch," 2 seconds, 5 seconds, 10 seconds, and 20 seconds [two epochs of 10 seconds of muscle activation with 1-2 seconds of rest between the two epochs]).

Thenar muscle activation--maximum, voluntary, isometric

Other

Each subject will perform maximum, voluntary, isometric muscle activation (of the target muscle) for each of various durations ("single brief muscle twitch," 2 seconds, 5 seconds, 10 seconds, and 20 seconds [two epochs of 10 seconds of muscle activation with 1-2 seconds of rest between the two epochs]).

EDB muscle activation--maximum, voluntary, isometric

Other

Each subject will perform maximum, voluntary, isometric muscle activation (of the target muscle) for each of various durations ("single brief muscle twitch," 2 seconds, 5 seconds, 10 seconds, and 20 seconds [two epochs of 10 seconds of muscle activation with 1-2 seconds of rest between the two epochs]).

Relaxation of muscle

Other

The muscle on the opposite side will be maintained at rest.

Primary outcomes

  1. Ulnar-Hypothenar CMAP Amplitude

    Time frame: Immediate, 5 sec, 10 sec, 15 sec, 20 sec, 30 sec, 60 sec, 90 sec, 2 minutes, and each minute up to 40 minutes (or return to pre-activation value)

    Amplitude (baseline to negative peak) of the compound muscle action potential (CMAP) recorded from the hypothenar eminence after stimulation of the ulnar nerve at the wrist

  2. Ulnar-Hypothenar CMAP Area

    Time frame: Immediate, 5 sec, 10 sec, 15 sec, 20 sec, 30 sec, 60 sec, 90 sec, 2 minutes, and each minute up to 40 minutes (or return to pre-activation value)

    Area (under the negative curve) of the compound muscle action potential (CMAP) recorded from the hypothenar eminence after stimulation of the ulnar nerve at the wrist

  3. Median-Thenar CMAP Amplitude

    Time frame: Immediate, 5 sec, 10 sec, 15 sec, 20 sec, 30 sec, 60 sec, 90 sec, 2 minutes, and each minute up to 40 minutes (or return to pre-activation value)

    Amplitude (baseline to negative peak) of the compound muscle action potential (CMAP) recorded from the thenar eminence after stimulation of the median nerve at the wrist

  4. Median-Thenar CMAP Area

    Time frame: Immediate, 5 sec, 10 sec, 15 sec, 20 sec, 30 sec, 60 sec, 90 sec, 2 minutes, and each minute up to 40 minutes (or return to pre-activation value)

    Area (under the negative curve) of the compound muscle action potential (CMAP) recorded from the thenar eminence after stimulation of the median nerve at the wrist

  5. Peroneal-EDB CMAP Amplitude

    Time frame: Immediate, 5 sec, 10 sec, 15 sec, 20 sec, 30 sec, 60 sec, 90 sec, 2 minutes, and each minute up to 40 minutes (or return to pre-activation value)

    Amplitude (baseline to negative peak) of the compound muscle action potential (CMAP) recorded from the extensor digitorum brevis muscle (EDB) after stimulation of the peroneal nerve at the ankle

  6. Peroneal-EDB CMAP Area

    Time frame: Immediate, 5 sec, 10 sec, 15 sec, 20 sec, 30 sec, 60 sec, 90 sec, 2 minutes, and each minute up to 40 minutes (or return to pre-activation value)

    Area (under the negative curve) of the compound muscle action potential (CMAP) recorded from the extensor digitorum brevis muscle (EDB) after stimulation of the peroneal nerve at the ankle

Secondary outcomes

  1. Ulnar-Hypothenar CMAP Duration

    Time frame: Immediate, 5 sec, 10 sec, 15 sec, 20 sec, 30 sec, 60 sec, 90 sec, 2 minutes, and each minute up to 40 minutes (or return to pre-activation value)

    Duration (of the negative curve) of the compound muscle action potential (CMAP) recorded from the hypothenar eminence after stimulation of the ulnar nerve at the wrist

  2. Median-Thenar CMAP Duration

    Time frame: Immediate, 5 sec, 10 sec, 15 sec, 20 sec, 30 sec, 60 sec, 90 sec, 2 minutes, and each minute up to 40 minutes (or return to pre-activation value)

    Duration (of the negative curve) of the compound muscle action potential (CMAP) recorded from the thenar eminence after stimulation of the median nerve at the wrist

  3. Peroneal-EDB CMAP Duration

    Time frame: Immediate, 5 sec, 10 sec, 15 sec, 20 sec, 30 sec, 60 sec, 90 sec, 2 minutes, and each minute up to 40 minutes (or return to pre-activation value)

    Duration (of the negative curve) of the compound muscle action potential (CMAP) recorded from the extensor digitorum brevis muscle (EDB) after stimulation of the peroneal nerve at the ankle

  4. Size of the CMAP from the Contralateral Limb Muscle While at Rest

    Time frame: Record periodically (every 1-15 minutes)

    The amplitude, area, and duration of the compound muscle action potential (CMAP) recorded from the contralateral muscle (Ulnar-Hypothenar, Median-Thenar, or Peroneal-EDB) will be determined as this contralateral muscle stays at rest.

  5. F Wave Size and Persistence

    Time frame: Periodically

    F waves may be determined and the size and persistence of the F wave may be determined at baseline and if the amplitude of the direct response recorded from the muscle (on either the side of muscle activation or the side continuing at rest) with nerve stimulation changes by more than a small amount.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

The Effect of Prior Muscle Activation on the Compound Muscle Action Potential (CMAP)- Implications for Routine Nerve Conduction Studies (NCS) and Serial NCS

Important dates

Study start
2010
Primary completion
2011
Study completion
2019
First posted
Aug 17, 2010
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.