Phase I: Electrical Stimulation for Critically Ill Covid-19 Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active E-Stim 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 an active electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).
|
| Sham Comparator: sham E-Stim 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 a sham electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).
|
Outcome Measures
Primary Outcome Measures
- Change in Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation [an average of 2 weeks (Phase I)]
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).
- Change in Ankle Strength [an average of 2 weeks (Phase I)]
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).
- Change in Gastrocnemius Muscle Strength [an average of 2 weeks (Phase I)]
Gastrocnemius muscle strength will be measured by surface electromyography (Delsys Trino Wireless EMG System, MA, US) in response to the average of three 5-second dorsiflexion MVIC per 30 seconds of relaxation in-between.
Secondary Outcome Measures
- Change in Plantar Tissue Oxygen Saturation/Consumption [an average of 2 weeks (Phase I)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
COVID-19 test positive critically ill patients in need of assisted ventilation requiring care in the intensive care unit
-
COVID-19 test positive critically ill patients in need of assisted ventilation requiring prolonged care in the hospital
Exclusion Criteria:
-
Paralyzed patients (i.e., rocuronium, cisatracurium) at the moment of enrollment
-
Patients under vasopressor therapy (i.e., norepinephrine, epinephrine, vasopressin) at the moment of enrollment
-
Patients expected to be discharged in the next 24 hours
-
Patient has a demand-type cardiac pacemaker, implanted defibrillator or other implanted electronic device.
-
Active wound infection
-
Below the knee amputations
-
Based on the clinicians decision whether the patient is eligible for the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Baylor College of Medicine
- Avazzia, Inc
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- H-47781-A
Study Results
Participant Flow
| Recruitment Details | Patients were randomized into intervention (n=9), and control (n=10) groups. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Active E-Stim (Phase I) | Sham E-Stim (Phase I) |
|---|---|---|
| Arm/Group Description | Subjects will receive an active electrical stimulation device to wear for 1 hour daily for up to 2 weeks. | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for up to 2 weeks. |
| Period Title: Overall Study | ||
| STARTED | 9 | 10 |
| COMPLETED | 8 | 7 |
| NOT COMPLETED | 1 | 3 |
Baseline Characteristics
| Arm/Group Title | Active E-Stim (Phase I) | Sham E-Stim (Phase I) | Total |
|---|---|---|---|
| Arm/Group Description | Subjects enrolled in Phase I will receive an active electrical stimulation device to wear for 1 hour daily for up to 2 weeks. | Subjects enrolled in Phase I will receive a sham electrical stimulation device to wear for 1 hour daily for up to 2 weeks. | Total of all reporting groups |
| Overall Participants | 9 | 10 | 19 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
3
33.3%
|
5
50%
|
8
42.1%
|
| >=65 years |
6
66.7%
|
5
50%
|
11
57.9%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
67.9
(3.3)
|
63.7
(2.9)
|
65.8
(3.1)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
5
55.6%
|
3
30%
|
8
42.1%
|
| Male |
4
44.4%
|
7
70%
|
11
57.9%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
10%
|
1
5.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
22.2%
|
3
30%
|
5
26.3%
|
| White |
2
22.2%
|
1
10%
|
3
15.8%
|
| More than one race |
5
55.6%
|
5
50%
|
10
52.6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Change in Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Active E-Stim (Phase I) | Sham E-Stim (Phase I) |
|---|---|---|
| Arm/Group Description | Subjects will receive an active electrical stimulation device to wear for 1 hour daily for up to 2 weeks. | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for up to 2 weeks. |
| Measure Participants | 9 | 10 |
| Mean (Standard Deviation) [milliVolts] |
334.9
(0.65)
|
322.7
(4.9)
|
| Title | Change in Ankle Strength |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Active E-Stim (Phase I) | Sham E-Stim (Phase I) |
|---|---|---|
| Arm/Group Description | Subjects will receive an active electrical stimulation device to wear for 1 hour daily for up to 2 weeks. | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for up to 2 weeks. |
| Measure Participants | 9 | 10 |
| Mean (Standard Deviation) [kg] |
3.1
(0.4)
|
2.9
(0.6)
|
| Title | Change in Gastrocnemius Muscle Strength |
|---|---|
| Description | Gastrocnemius muscle strength will be measured by surface electromyography (Delsys Trino Wireless EMG System, MA, US) in response to the average of three 5-second dorsiflexion MVIC per 30 seconds of relaxation in-between. |
| Time Frame | an average of 2 weeks (Phase I) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Active E-Stim (Phase I) | Sham E-Stim (Phase I) |
|---|---|---|
| Arm/Group Description | Subjects will receive an active electrical stimulation device to wear for 1 hour daily for up to 2 weeks. | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for up to 2 weeks. |
| Measure Participants | 9 | 10 |
| Mean (Standard Deviation) [milliVolts] |
6.6
(0.1)
|
6.5
(0.1)
|
| Title | Change in Plantar Tissue Oxygen Saturation/Consumption |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Active E-Stim (Phase I) | Sham E-Stim (Phase I) |
|---|---|---|
| Arm/Group Description | Subjects will receive an active electrical stimulation device to wear for 1 hour daily for up to 2 weeks. | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for up to 2 weeks. |
| Measure Participants | 9 | 10 |
| Mean (Standard Deviation) [Percentage of oxygen saturation] |
70.1
(1.9)
|
65.5
(2.1)
|
Adverse Events
| Time Frame | an average of 2 weeks(phase I) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Serious adverse events related to electrical stimulation therapy (e.g. pain, muscle damage, skin irritation) will be collected during the study. | |||
| Arm/Group Title | Active E-Stim (Phase I) | Sham E-Stim (Phase I) | ||
| Arm/Group Description | During Phase I of the study, four electrode pads will be placed in the proximal and distal gastrocnemius muscle of each participant in order to receive electrical stimulation therapy for 1 hour during hospitalization for an average of 2 weeks. Adverse events related to electrical stimulation therapy (i.e., pain, muscle damage, skin irritation) will be collected. | During Phase I of the study, four electrode pads will be placed in the proximal and distal gastrocnemius muscle of each participant in order to receive electrical stimulation therapy for 1 hour during hospitalization for an average of 2 weeks. Adverse events related to electrical stimulation therapy (i.e., pain, muscle damage, skin irritation) will be collected. However, the sham group will receive an inactive device. So, electrical stimulation will only be provided to quantify the study outcomes. Adverse events will also be reported during this time. | ||
All Cause Mortality |
||||
| Active E-Stim (Phase I) | Sham E-Stim (Phase I) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/9 (11.1%) | 3/10 (30%) | ||
Serious Adverse Events |
||||
| Active E-Stim (Phase I) | Sham E-Stim (Phase I) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/10 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Active E-Stim (Phase I) | Sham E-Stim (Phase I) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/10 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Prof. Bijan Najafi |
|---|---|
| Organization | Baylor College of Medicine |
| Phone | 7137987536 |
| bijan.najafi@bcm.edu |
- H-47781-A