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

NCT ID: NCT01182558

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2019-08-31

Brief Summary

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.

Detailed Description

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.

Conditions

Focus: Effect of Muscle Activation on CMAP in Normal Humans

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Activation of Hypothenar Eminence

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

Group Type: OTHER

Hypothenar muscle activation--maximum, voluntary, isometric

Intervention Type: 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 \[two epochs of 10 seconds of muscle activation with 1-2 seconds of rest between the two epochs\]).

Activation of Thenar Eminence

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

Group Type: OTHER

Thenar muscle activation--maximum, voluntary, isometric

Intervention Type: 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 \[two epochs of 10 seconds of muscle activation with 1-2 seconds of rest between the two epochs\]).

Activation of Extensor Digitorum Brevis

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

Group Type: OTHER

EDB muscle activation--maximum, voluntary, isometric

Intervention Type: 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 \[two epochs of 10 seconds of muscle activation with 1-2 seconds of rest between the two epochs\]).

Maintain Relaxation of the Opposite Side

While the muscle of the right side is activated periodically and the compound muscle action potential is tested frequently, the muscle on the left side is maintained at rest and the compound muscle action potential is tested infrequently.

Group Type: PLACEBO_COMPARATOR

Relaxation of muscle

Intervention Type: OTHER

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

Interventions

Hypothenar muscle activation--maximum, voluntary, isometric

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 \[two epochs of 10 seconds of muscle activation with 1-2 seconds of rest between the two epochs\]).

Intervention Type: OTHER

Thenar muscle activation--maximum, voluntary, isometric

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 \[two epochs of 10 seconds of muscle activation with 1-2 seconds of rest between the two epochs\]).

Intervention Type: OTHER

EDB muscle activation--maximum, voluntary, isometric

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 \[two epochs of 10 seconds of muscle activation with 1-2 seconds of rest between the two epochs\]).

Intervention Type: OTHER

Relaxation of muscle

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Gordon Peterson

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gordon W. Peterson, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Loma Linda, California, United States

Countries

United States

References

Peterson GW, Tsao BE, Nist LD, Estevez D, Brandstater ME. Prior muscle activation affects the compound muscle action potential. Muscle Nerve. 2019 Jul;60(1):25-31. doi: 10.1002/mus.26463. Epub 2019 Mar 25.

Reference Type: BACKGROUND

PMID: 30847939 (View on PubMed)

Other Identifiers

5100161

Identifier Type: -

Identifier Source: org_study_id