Focus: Effect of Muscle Activation on CMAP in Normal HumansNCT01182558
The Effect of Prior Muscle Activation on the Compound Muscle Action Potential (CMAP)
A study testing Hypothenar muscle activation--maximum, voluntary, isometric, Thenar muscle activation--maximum, voluntary, isometric and EDB muscle activation--maximum, voluntary, isometric in people with Focus: Effect of Muscle Activation on CMAP in Normal Humans, run by Loma Linda University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus: Effect of Muscle Activation on CMAP in Normal Humans
- What is being tested?
- Hypothenar muscle activation--maximum, voluntary, isometric, Thenar muscle activation--maximum, voluntary, isometric and EDB muscle activation--maximum, voluntary, isometric
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Aug 2019
- Phase
- Interventional
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal, healthy volunteers
- Age 18-49
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Neurology - Faculty Physicians and Surgeons of Loma Linda University School of Medicine
Loma Linda, California, 92354
About this study
Official title: The Effect of Prior Muscle Activation on the Compound Muscle Action Potential (CMAP)- Implications for Routine Nerve Conduction Studies (NCS) and Serial NCS
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.
Read the 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.
- Being tested
- Hypothenar muscle activation--maximum, voluntary, isometric, Thenar muscle activation--maximum, voluntary, isometric, EDB muscle activation--maximum, voluntary, isometric, Relaxation of muscle
- Keywords
- Muscle, Activation, Effect, Compound muscle action potential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypothenar muscle activation--maximum, voluntary, isometricOther
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, isometricOther
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, isometricOther
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 muscleOther
The muscle on the opposite side will be maintained at rest.
| Study group | Role | What they receive |
|---|---|---|
| Activation of Hypothenar Eminence | Other | 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]). Receives: Other: Hypothenar muscle activation--maximum, voluntary, isometric |
| Activation of Thenar Eminence | Other | 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]). Receives: Other: Thenar muscle activation--maximum, voluntary, isometric |
| Activation of Extensor Digitorum Brevis | Other | 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]). Receives: Other: EDB muscle activation--maximum, voluntary, isometric |
| Maintain Relaxation of the Opposite Side | Placebo comparator | 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. Receives: Other: Relaxation of muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulnar-Hypothenar CMAP Amplitude
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
Measured: 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)
Ulnar-Hypothenar CMAP Area
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
Measured: 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)
Median-Thenar CMAP Amplitude
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
Measured: 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)
Median-Thenar CMAP Area
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
Measured: 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)
Peroneal-EDB CMAP Amplitude
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
Measured: 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)
Peroneal-EDB CMAP Area
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
Measured: 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)
Secondary outcomes (5)
Ulnar-Hypothenar CMAP Duration
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
Measured: 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)
Median-Thenar CMAP Duration
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
Measured: 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)
Peroneal-EDB CMAP Duration
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
Measured: 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)
Size of the CMAP from the Contralateral Limb Muscle While at Rest
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.
Measured: Record periodically (every 1-15 minutes)
F Wave Size and Persistence
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.
Measured: Periodically
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2011
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Focus: Effect of Muscle Activation on CMAP in Normal HumansStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gordon Peterson, Loma Linda University
- Investigators
- Gordon W. Peterson, MD, Principal investigator, Neurology, Faculty Physicians and Surgeons of Loma Linda University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182558
- Sponsor's protocol ID
- 5100161
- Status last verified
- Aug 2019
- First submitted
- 12 Aug 2010
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30847939
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prior Muscle Activation on the Compound Muscle Action Potential (CMAP)- Implications for Routine Nerve Conduction Studies (NCS) and Serial NCS
- ClinicalTrials.gov ID
- NCT01182558
- Acronym / sponsor ID
- 5100161
- Keywords
- Muscle, Activation, Effect, Compound muscle action potential
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 17 Aug 2010 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Activation of Hypothenar Eminence | Other | Other: Hypothenar muscle activation--maximum, voluntary, isometricEach 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]). |
| Activation of Thenar Eminence | Other | Other: Thenar muscle activation--maximum, voluntary, isometricEach 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]). |
| Activation of Extensor Digitorum Brevis | Other | Other: EDB muscle activation--maximum, voluntary, isometricEach 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]). |
| Maintain Relaxation of the Opposite Side | Placebo comparator | Other: Relaxation of muscleWhile 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normal, healthy volunteers
- Age 18-49
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypothenar muscle activation--maximum, voluntary, isometricEach 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]). | Other | Activation of Hypothenar Eminence |
| Thenar muscle activation--maximum, voluntary, isometricEach 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]). | Other | Activation of Thenar Eminence |
| EDB muscle activation--maximum, voluntary, isometricEach 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]). | Other | Activation of Extensor Digitorum Brevis |
| Relaxation of muscleThe muscle on the opposite side will be maintained at rest. | Other | Maintain Relaxation of the Opposite Side |
Primary outcome
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
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
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
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
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
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
5 secondary outcomes
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)
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)
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)
Size of the CMAP from the Contralateral Limb Muscle While at Rest
Time frame: Record periodically (every 1-15 minutes)
F Wave Size and Persistence
Time frame: Periodically
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 14 Aug 2019.
- Background: PubMed 30847939Peterson 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.
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.
Gordon W. Peterson, MD principal investigator
Neurology, Faculty Physicians and Surgeons of Loma Linda University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypothenar muscle activation--maximum, voluntary, isometric, Thenar muscle activation--maximum, voluntary, isometric and EDB muscle activation--maximum, voluntary, isometric in people with Focus: Effect of Muscle Activation on CMAP in Normal Humans, run by Loma Linda University 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 2 inclusion and 8 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 14 Aug 2019. 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. Some participants in this study may receive a placebo. 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?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01182558, which also lists 1 linked publication.
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 14 Aug 2019.