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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.
20 subjects that were hospitalized due to severe COVID-19 infection and present neuromuscular complications (i.e., hospital acquired weakness due to neuromyopathy) will be recruited after the first phase of this study is completed. Unlike Phase I (study for prevention), this is a proof of concept randomized control trial (RCT) study for recovery. The patients will be recruited from the COVID-19 Clinic at Baylor College of Medicine and will begin the study after being diagnosed with neuromyopathy due to prolonged hospitalization for COVID-19. This will be performed by a critical care and pulmonary specialist at the BCM COVID-19 Clinic. The entire cohort will receive daily electrical stimulation in lower extremity (e.g. Gastrocnemius, tibial anterior muscle) up to 1 hour to recover from Neuromyopathy complications and prolonged hospital stay. Participants will be randomized to intervention (IG) or control group (CG)). 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. In addition to taking the device home to deliver electrical stimulation themselves, the patients will attend a weekly assessment at the McNair Campus for up to 4 weeks. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active E-Stim | Active Comparator | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). |
|
| Electrical Stimulation - Sham | Sham Comparator | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). |
|
| 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 for 4 weeks (phase II). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 4 weeks (Phase II) |
| 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 4 weeks (phase II). |
| Measure | Description | Time Frame |
|---|---|---|
| Plantar Oxyhemoglobin | Percentage of oxyhemoglobin (OxyHb) 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 OxyHb level in superficial tissue. The metatarsus area including the five toes will be traced. Data reported includes plantar oxyhemoglobin after 10 minutes of stopping 1 hour of electrical stimulation therapy. |
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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 |
|---|---|---|---|
| 36905161 | Derived | Zulbaran-Rojas A, Lee M, Bara RO, Flores-Camargo A, Spitz G, Finco MG, Bagheri AB, Modi D, Shaib F, Najafi B. Electrical stimulation to regain lower extremity muscle perfusion and endurance in patients with post-acute sequelae of SARS CoV-2: A randomized controlled trial. Physiol Rep. 2023 Mar;11(5):e15636. doi: 10.14814/phy2.15636. |
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Please note that these results only include Post-Covid-19 Patients (Phase II).
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| ID | Title | Description |
|---|---|---|
| FG000 | Active E-Stim | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). Electrical Stimulation: Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). |
| FG001 | Electrical Stimulation - Sham | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). Electrical Stimulation - Sham: Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active E-Stim | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). Electrical Stimulation: Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). |
| BG001 | Electrical Stimulation - Sham |
| 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 | 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 Error | miliVolts | an average of 4 weeks (Phase II) |
|
1 month
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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 | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). Electrical Stimulation: Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2022 | Dec 21, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 19, 2022 | Dec 21, 2022 | ICF_001.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. Gastrocnemius muscle) for up to 1 hour. The EE device will be functional for IG and non-functional for CG.
Phase II will include previously hospitalized patients (n=20) who had recover from severe COVID-19 infection, but present persistent neuromuscular sequelae. This will be performed in an outpatient clinic. The time frame will be 4 weeks.
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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 for 4 weeks (phase II). |
|
| an average of 4 weeks (phase II) |
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). Electrical Stimulation - Sham: Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).
Electrical Stimulation - Sham: Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).
|
|
| Primary | 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 4 weeks (phase II). |
|
|
|
| Secondary | Plantar Oxyhemoglobin | Percentage of oxyhemoglobin (OxyHb) 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 OxyHb level in superficial tissue. The metatarsus area including the five toes will be traced. Data reported includes plantar oxyhemoglobin after 10 minutes of stopping 1 hour of electrical stimulation therapy. | Posted | Mean | Standard Deviation | Percentage of oxyhemoglobin | an average of 4 weeks (phase II) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Electrical Stimulation - Sham | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). Electrical Stimulation - Sham: Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). | 0 | 8 | 0 | 8 | 0 | 8 |
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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 |