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| Name | Class |
|---|---|
| Avazzia, Inc | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active E-Stim | Active Comparator | 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 E-Stim | Sham Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical Stimulation | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | an average of 2 weeks (Phase I) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | an average of 2 weeks (Phase I) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Scale: Minimum score or low risk: < 24 points Medium score or Moderate risk: 25-45 points Maximum score or high risk: > 45 points. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36561714 | Derived | Zulbaran-Rojas A, Mishra R, Rodriguez N, Bara RO, Lee M, Bagheri AB, Herlihy JP, Siddique M, Najafi B. Safety and efficacy of electrical stimulation for lower-extremity muscle weakness in intensive care unit 2019 Novel Coronavirus patients: A phase I double-blinded randomized controlled trial. Front Med (Lausanne). 2022 Dec 6;9:1017371. doi: 10.3389/fmed.2022.1017371. eCollection 2022. |
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Patients were randomized into intervention (n=9), and control (n=10) groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active E-Stim (Phase I) | Subjects will receive an active electrical stimulation device to wear for 1 hour daily for up to 2 weeks. |
| FG001 | Sham E-Stim (Phase I) | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for up to 2 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active E-Stim (Phase I) | Subjects enrolled in Phase I will receive an active electrical stimulation device to wear for 1 hour daily for up to 2 weeks. |
| BG001 | Sham E-Stim (Phase I) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | milliVolts | an average of 2 weeks (Phase I) |
|
an average of 2 weeks(phase I)
Serious adverse events related to electrical stimulation therapy (e.g. pain, muscle damage, skin irritation) will be collected during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active E-Stim (Phase I) | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Bijan Najafi | Baylor College of Medicine | 7137987536 | bijan.najafi@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 21, 2021 | Oct 8, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 21, 2021 | Nov 4, 2021 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 18, 2020 | Oct 8, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D009133 | Muscular Atrophy |
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
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Participants will be randomized to intervention (IG) or control group (CG) with ratio of 1:1. The entire cohort will receive daily electrical stimulation (EE) in lower extremity (e.g. Gastronemius muscle) for up to 1 hour. The EE device will be functional for IG and non-functional for CG.
Phase I will include patients (n=19) admitted to the hospital due to severe COVID-19 infection. The time frame for therapy will be 2 weeks or until hospital discharge, whichever comes first.
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Devices may be active or sham.
| Electrical Stimulation - Sham | Device | 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). |
|
| 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). | An average of 2 weeks (Phase I) |
Subjects enrolled in Phase I will receive a sham electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | kg | an average of 2 weeks (Phase I) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Percentage of oxygen saturation | an average of 2 weeks (Phase I) |
|
|
|
| Other Pre-specified | 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:
Scale: Minimum score or low risk: < 24 points Medium score or Moderate risk: 25-45 points Maximum score or high risk: > 45 points. | Posted | Mean | Standard Deviation | score on a scale | an average of 2 weeks (Phase I) |
|
|
|
| Other Pre-specified | 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). | Posted | Mean | Standard Deviation | milliVolts | An average of 2 weeks (Phase I) |
|
|
|
| 1 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Sham E-Stim (Phase I) | 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. | 3 | 10 | 0 | 10 | 0 | 10 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |