An interventional study of Clinical Electrical Stimulator in ICU Acquired Weakness, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-19.
Sponsored by Emory University · Not applicable, Interventional, and Diagnostic
The goal of this study is to develop a non-invasive test to diagnose intensive care unit (ICU) acquired weakness that can be administered to both responsive and non-responsive patients. Study participation will involve the measurement of muscle fatigue during a single 30 minute session. Skeletal muscle will be stimulated with an FDA approved clinical electrical stimulator and accelerations will be passively recorded with an accelerometer.
The primary purpose of this study is to develop a procedure to identify intensive care unit (ICU) acquired weakness. This condition occurs in a subset of people admitted into the ICU, and is associated with a 30% increased risk of death before discharge from the ICU. There are currently major limitations in the ability to diagnose ICU acquired weakness, making it difficult to study. The goal is to develop a non-invasive test that can be administered to both responsive and non-responsive patients. The current proposal will focus on replicating the results of previous research using motion detecting accelerometers to measure fatigue in human skeletal muscles. This study is designed to test out the procedures in patients who have been transferred from the ICU to a lower level of care so that follow-on studies can be designed to help mitigate this condition in the ICU.
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This study's enrollment of 22 is below the median of 42 across 84 interventional studies indexed under Asthenia.
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Exclusion Criteria:
Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Device: Clinical Electrical Stimulator
Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Device: Clinical Electrical Stimulator
Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
Also known as: Vectra Genisys Therapy System
Peak Acceleration Measured in Extensor Carpi Radialis Longus
The highest acceleration over a single muscle twitch will be used as the peak acceleration. Peak acceleration will be measured in acceleration in number of times gravity (g). Higher twitch acceleration is a better response.
Time frame: Day 1
Peak Acceleration Measured in Tibialis Anterior
The highest acceleration over a single muscle twitch will be used as the peak acceleration. Peak acceleration will be measured in acceleration in number of times gravity (g). Higher twitch acceleration is a better response.
Time frame: Day 1
Time to Peak Acceleration Measured in Extensor Carpi Radialis Longus
The time, in seconds, until peak acceleration is reached will be assessed at 2, 4 and 6 Hz. There is not a reference range for the time to peak force and at this time it is unclear if a shorter or longer time to peak force indicates a more desirable state of health.
Time frame: Day 1 at 2 Hz, Day 1 at 4 Hz, Day 1 at 6 Hz
Time to Peak Acceleration Measured in Tibialis Anterior
The time, in seconds, until peak acceleration is reached will be assessed. There is not a reference range for the time to peak force and at this time it is unclear if a shorter or longer time to peak force indicates a more desirable state of health.
Time frame: Day 1
End Acceleration Measured in Extensor Carpi Radialis Longus
End acceleration is the twitch acceleration averaged over 5 twitches over the last second of stable twitches within the stimulation period. A reference range has not yet been established for this measurement.
Time frame: Day 1
End Acceleration Measured in Tibialis Anterior
End acceleration is the twitch acceleration averaged over 5 twitches over the last second of stable twitches within the stimulation period. A reference range has not yet been established for this measurement.
Time frame: Day 1
Fatigue Ratio Measured in Extensor Carpi Radialis Longus
Fatigue ratio is the ending acceleration divided by peak acceleration during a given stimulation period. A reference range has not yet been established for this measurement. A higher ratio indicates less change from maximum. A lower score would indicate worse outcome.
Time frame: Day 1
Fatigue Ratio Measured in Tibialis Anterior
Fatigue ratio is the ending acceleration divided by peak acceleration during a given stimulation period. A reference range has not yet been established for this measurement.
Time frame: Day 1
| Milestone | ICU Acquired Weakness Group | No ICU Acquired Weakness Group |
|---|---|---|
| Started | 5 | 17 |
| Completed | 5 | 16 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
The highest acceleration over a single muscle twitch will be used as the peak acceleration. Peak acceleration will be measured in acceleration in number of times gravity (g). Higher twitch acceleration is a better response.
| units of Gravity | ICU Acquired Weakness Group | No ICU Acquired Weakness Group |
|---|---|---|
| Twitch acceleration at 20 Hz | 0.476 ± 0.467 | 1.639 ± 0.772 |
| Twitch acceleration at 40 Hz | 0.541 ± 0.591 | 1.608 ± 0.803 |
| Twitch acceleration at 60Hz | 0.373 ± 0.402 | 1.300 ± 0.662 |
The highest acceleration over a single muscle twitch will be used as the peak acceleration. Peak acceleration will be measured in acceleration in number of times gravity (g). Higher twitch acceleration is a better response.
| Units of Gravity | ICU Acquired Weakness Group | No ICU Acquired Weakness Group |
|---|---|---|
| Twitch acceleration at 20 Hz | 0.105 ± 0.151 | 1.115 ± 0.677 |
| Twitch acceleration at 40 Hz | 0.102 ± 0.144 | 1.029 ± 0.585 |
| Twitch acceleration at 60 Hz | 0.101 ± 0.153 | 0.593 ± 0.494 |
The time, in seconds, until peak acceleration is reached will be assessed at 2, 4 and 6 Hz. There is not a reference range for the time to peak force and at this time it is unclear if a shorter or longer time to peak force indicates a more desirable state of health.
| Seconds | ICU Acquired Weakness Group | No ICU Acquired Weakness Group |
|---|---|---|
| Day 1 at 2 Hz | 64.7 ± 69.3 | 119.5 ± 55.1 |
| Day 1 at 4 Hz | 9.8 ± 14.1 | 64.6 ± 56.2 |
| Day 1 at 6 Hz | 1.5 ± 1.8 | 33.7 ± 53.2 |
The time, in seconds, until peak acceleration is reached will be assessed. There is not a reference range for the time to peak force and at this time it is unclear if a shorter or longer time to peak force indicates a more desirable state of health.
| Seconds | ICU Acquired Weakness Group | No ICU Acquired Weakness Group |
|---|---|---|
| Day 1 at 2 Hz | 45.5 ± 68.6 | 100.1 ± 53.0 |
| Day 1 at 4 Hz | 22.0 ± 47.9 | 32.3 ± 43.3 |
| Day 1 at 6 Hz | 8.8 ± 19.6 | 19.3 ± 27.1 |
End acceleration is the twitch acceleration averaged over 5 twitches over the last second of stable twitches within the stimulation period. A reference range has not yet been established for this measurement.
| Units of Gravity | ICU Acquired Weakness Group | No ICU Acquired Weakness Group |
|---|---|---|
| Twitch acceleration at 20 Hz | 0.289 ± 0.328 | 1.383 ± 0.524 |
| Twitch acceleration at 40 Hz | 0.147 ± 0.161 | 1.021 ± 0.755 |
| Twitch acceleration at 60 Hz | 0.239 ± 0.263 | 1.133 ± 0.521 |
End acceleration is the twitch acceleration averaged over 5 twitches over the last second of stable twitches within the stimulation period. A reference range has not yet been established for this measurement.
| Units of Gravity | ICU Acquired Weakness Group | No ICU Acquired Weakness Group |
|---|---|---|
| Twitch acceleration at 20 Hz | 0.057 ± 0.081 | 1.088 ± 0.703 |
| Twitch acceleration at 40 Hz | 0.042 ± 0.067 | 0.767 ± 0.517 |
| Twitch acceleration at 60 Hz | 0.059 ± 0.083 | 0.640 ± 0.565 |
Fatigue ratio is the ending acceleration divided by peak acceleration during a given stimulation period. A reference range has not yet been established for this measurement. A higher ratio indicates less change from maximum. A lower score would indicate worse outcome.
| ratio | ICU Acquired Weakness Group | No ICU Acquired Weakness Group |
|---|---|---|
| Twitch acceleration at 20 Hz | 0.578 ± 0.266 | 0.862 ± 0.284 |
| Twitch acceleration at 40 Hz | 0.306 ± 0.194 | 0.562 ± 0.349 |
| Twitch acceleration at 60 Hz | 0.639 ± 0.136 | 0.707 ± 0.223 |
Fatigue ratio is the ending acceleration divided by peak acceleration during a given stimulation period. A reference range has not yet been established for this measurement.
| ratio | ICU Acquired Weakness Group | No ICU Acquired Weakness Group |
|---|---|---|
| Twitch acceleration at 2 Hz | 0.610 ± 0.364 | 0.899 ± 0.351 |
| Twitch acceleration at 4 Hz | 0.471 ± 0.414 | 0.572 ± 0.247 |
| Twitch acceleration at 6 Hz | 0.437 ± 0.414 | 0.549 ± 0.265 |
Collected over Day 1. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ICU Acquired Weakness Group | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| No ICU Acquired Weakness Group | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Categorical(Participants) | ICU Acquired Weakness Group | No ICU Acquired Weakness Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 14 | 17 |
| >=65 years | 2 | 3 | 5 |
| Age, Continuous(years) | ICU Acquired Weakness Group | No ICU Acquired Weakness Group | Total |
|---|---|---|---|
| Mean | 49.5 ± 21.3 | 44.6 ± 21.4 | 45.5 ± 21.0 |
| Sex: Female, Male(Participants) | ICU Acquired Weakness Group | No ICU Acquired Weakness Group | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 4 | 15 | 19 |
| Ethnicity (NIH/OMB)(Participants) | ICU Acquired Weakness Group | No ICU Acquired Weakness Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 4 | 4 |
| Not Hispanic or Latino | 5 | 13 | 18 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | ICU Acquired Weakness Group | No ICU Acquired Weakness Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 11 | 16 |
| White | 0 | 2 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 4 | 4 |
| Region of Enrollment(participants) | ICU Acquired Weakness Group | No ICU Acquired Weakness Group | Total |
|---|---|---|---|
| United States | 5 | 17 | 22 |
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Plan to share: Yes — Individual participant data that underlie the results reported in the publications will be available for sharing, after deidentification.
Supporting information: Study protocol
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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