A Phase 1 interventional study of Electrical Stimulation and Electrical Stimulation - Sham in Covid19, Muscle Atrophy and Muscle Weakness, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-02-16.
Sponsored by Baylor College of Medicine · Phase 1, Interventional, and Supportive care
Unfortunately, hospital-acquired weakness is highly prevalent among COVID-19 hospitalized patients, who often require prolonged bed-rest or paralytics for an extended period of time in order to maintain oxygenation. Prolonged bed rest has been associated with pronounced loss of muscle mass that can exceed 10% over the 1st week, which leads to functional impairment and complications post-hospital discharge. Physical therapy and in-hospital mobility program may reduce the incident of hospital-acquired weakness, but they are often impractical for COVID-19 patients. In particular, conventional mobility programs are challenging for those who are being treated in an intensive Care Unit. The purpose of this study is to test feasibility and proof-of-concept effectiveness of daily use of lower extremity electrical stimulation (EE) therapy, as a practical solution to address lower extremity muscle deconditioning, to address chronic consequences of COVID-19 including hospital-acquired weakness.
Phase I:
The purpose of this study is to test feasibility and proof-of-concept effectiveness of lower extremity electrical stimulation (EE) therapy to prevent muscular complications of COVID-19 including hospital-acquired weakness and neuropathy. This is a proof of concept randomized control trial (RCT) study for prevention. Eligible participants (n=19 anticipated) will be recruited from the Baylor St. Luke's' Medical Center (Houston, Texas). To be eligible participants should be hospitalized because of COVID-19 infection and suspected to be at risk for hospital acquired-weakness based on judgment of clinical intensivist investigators. Participants will be excluded if they are paralyzed. Other exclusion criteria include blow the knee amputation, those who have a demand-type cardiac pacemaker, implanted defibrillator or other implanted electronic device; those with wound infection, and other conditions that may interfere with outcomes or increase the risk of the use EE based on judgement of clinicians.
The Investigators hypothesize that implementation of EE as means of regular activation of lower extremity muscle is feasible and acceptable for the target population and would help to retain lower extremity muscle mass, lower extremity tissue oxygen saturation and perfusion, and thus reducing the severity of hospital acquired weakness and potentially improve outcomes of treatment among COVID-19 patients.
Participants will be randomized to intervention (IG) or control group (CG)). The entire cohort will receive daily EE in lower extremity (e.g. Gastronemius, tibial anterior muscle) up to 1 hour. EE therapy will be provided using a bio-electric stimulation technology (BEST) platform (Tennant Biomodulator PRO®, AVAZZIA, Inc.). The EE device will be functional for IG and non-functional for CG. The primary outcomes include between group difference and change from the baseline in muscle endurance, muscle strength, lower extremity tissue oxygen saturation, neuropathy, and muscle atrophy. Outcomes will be assessed at baseline, time of discharge or 2 weeks, whichever comes first.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 19 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
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Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
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Exclusion Criteria:
Subjects will receive an active electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).
Device: Electrical Stimulation
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).
Device: Electrical Stimulation - Sham
Subjects will receive an active electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).
Change in Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation
Gastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).
Time frame: an average of 2 weeks (Phase I)
Change in Ankle Strength
Ankle strength will be measured in response to the average of three 5-second dorsiflexion maximum voluntary isometric contractions per 30 seconds of relaxation in-between using a dynamometer (RoMech Digital Hanging Scale).
Time frame: an average of 2 weeks (Phase I)
Change in Plantar Tissue Oxygen Saturation/Consumption
Percentage of tissue oxygen saturation (SatO2) will be measured using a validated near-infrared (NIR) camera (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Can) that detects an approximate value of real-time SatO2 level in superficial tissue. The metatarsus area including the five toes will be traced.
Time frame: an average of 2 weeks (Phase I)
Likelihood of Falling
Assessment via the total score of Morse Fall Scale, which is the sum of six variables' score depending on presence or absence of: 1. History of falling: Score 25 for falls during the present hospital admission or immediate history of physiological falls; if not, score 0. 2. Secondary diagnosis: 15 if there is more than one medical diagnosis; if not, score 0. 3. Ambulatory aids: 0 for walking without a walking aid, uses wheelchair, or is on bedrest; 15 for use of crutches, a cane, or a walker; 30 for ambulation clutching onto the furniture for support. 4. Intravenous therapy: 20 for intravenous apparatus or a heparin lock inserted; if not, score 0. 5. Gait: 0 if has a normal gait; 10 weak gait; 20 impaired gait. 6. Mental status: patient's own self-assessment; 0 if normal; 15 if impaired. Scale: Minimum score or low risk: \< 24 points Medium score or Moderate risk: 25-45 points Maximum score or high risk: \> 45 points.
Time frame: an average of 2 weeks (Phase I)
Change in Gastrocnemius Muscle Strength
Gastrocnemius Muscle Strength will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).
Time frame: An average of 2 weeks (Phase I)
Patients were randomized into intervention (n=9), and control (n=10) groups.
| Milestone | Active E-Stim (Phase I) | Sham E-Stim (Phase I) |
|---|---|---|
| Started | 9 | 10 |
| Completed | 8 | 8 |
| Not completed | 1 | 2 |
Gastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).
| milliVolts | Active E-Stim (Phase I) | Sham E-Stim (Phase I) |
|---|---|---|
| Change in Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation | 352 ± 37 | 323 ± 18 |
Ankle strength will be measured in response to the average of three 5-second dorsiflexion maximum voluntary isometric contractions per 30 seconds of relaxation in-between using a dynamometer (RoMech Digital Hanging Scale).
| kg | Active E-Stim (Phase I) | Sham E-Stim (Phase I) |
|---|---|---|
| Change in Ankle Strength | 3.0 ± 1.6 | 2.1 ± 0.7 |
Percentage of tissue oxygen saturation (SatO2) will be measured using a validated near-infrared (NIR) camera (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Can) that detects an approximate value of real-time SatO2 level in superficial tissue. The metatarsus area including the five toes will be traced.
| Percentage of oxygen saturation | Active E-Stim (Phase I) | Sham E-Stim (Phase I) |
|---|---|---|
| Change in Plantar Tissue Oxygen Saturation/Consumption | 69.2 ± 8.9 | 67.2 ± 9.5 |
Assessment via the total score of Morse Fall Scale, which is the sum of six variables' score depending on presence or absence of: 1. History of falling: Score 25 for falls during the present hospital admission or immediate history of physiological falls; if not, score 0. 2. Secondary diagnosis: 15 if there is more than one medical diagnosis; if not, score 0. 3. Ambulatory aids: 0 for walking without a walking aid, uses wheelchair, or is on bedrest; 15 for use of crutches, a cane, or a walker; 30 for ambulation clutching onto the furniture for support. 4. Intravenous therapy: 20 for intravenous apparatus or a heparin lock inserted; if not, score 0. 5. Gait: 0 if has a normal gait; 10 weak gait; 20 impaired gait. 6. Mental status: patient's own self-assessment; 0 if normal; 15 if impaired. Scale: Minimum score or low risk: \< 24 points Medium score or Moderate risk: 25-45 points Maximum score or high risk: \> 45 points.
| score on a scale | Active E-Stim (Phase I) | Sham E-Stim (Phase I) |
|---|---|---|
| Likelihood of Falling | 39.3 ± 11 | 46.2 ± 11.8 |
Gastrocnemius Muscle Strength will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).
| milliVolts | Active E-Stim | Sham E-Stim |
|---|---|---|
| Change in Gastrocnemius Muscle Strength | 6.5 ± 0.39 | 6.5 ± 0.36 |
Collected over an average of 2 weeks(phase I). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active E-Stim (Phase I) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) |
| Sham E-Stim (Phase I) | 3/10 (30%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Active E-Stim (Phase I) | Sham E-Stim (Phase I) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 5 | 8 |
| >=65 years | 6 | 5 | 11 |
| Age, Continuous(years) | Active E-Stim (Phase I) | Sham E-Stim (Phase I) | Total |
|---|---|---|---|
| Mean | 67.9 ± 3.3 | 63.7 ± 2.9 | 65.8 ± 3.1 |
| Sex: Female, Male(Participants) | Active E-Stim (Phase I) | Sham E-Stim (Phase I) | Total |
|---|---|---|---|
| Female | 5 | 3 | 8 |
| Male | 4 | 7 | 11 |
| Race (NIH/OMB)(Participants) | Active E-Stim (Phase I) | Sham E-Stim (Phase I) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 5 |
| White | 2 | 1 | 3 |
| More than one race | 5 | 5 | 10 |
| Unknown or Not Reported | 0 | 0 | 0 |
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