COVID-19Phase 2Phase IINCT05198466
Electrical Stimulation for Critically Ill Post-Covid-19 Patients
A Phase 2 study testing Electrical Stimulation in people with COVID-19 and Muscle Atrophy, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COVID-19, Muscle Atrophy, Muscle Weakness
- What is being tested?
- Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2021to 18 Aug 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-COVID-19 patients who required hospitalization due to COVID-19 severe infection.
- Post-COVID-19 patients who required hospitalization and present neuromuscular sequelae due to COVID-19 severe infection.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrical Stimulation Therapy for Recovery of Hospital-acquired Weakness in Critically Ill COVID-19 Patients - A Proof of Concept Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- COVID-19, Muscle Atrophy, Muscle Weakness
- Being tested
- Electrical Stimulation, Electrical Stimulation - Sham
- Keywords
- Electrical Stimulation, Skin perfusion, Muscle dysfunction
- Medical subject headings
- COVID-19, Muscular Atrophy, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical StimulationDevice
Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).
Electrical Stimulation - ShamDevice
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).
| Study group | Role | What they receive |
|---|---|---|
| Active E-Stim | Active comparator | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). Receives: Device: Electrical Stimulation |
| Electrical Stimulation - Sham | Sham comparator | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). Receives: Device: Electrical Stimulation - Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: an average of 4 weeks (phase II).
Secondary outcomes (1)
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.
Measured: an average of 4 weeks (phase II)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start18 Aug 2021
- Primary completion18 Aug 2022
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Avazzia, Inc
- Responsible party
- Principal investigator, Bijan Najafi, PhD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198466
- Sponsor's protocol ID
- H-47781-B
- Acronym
- Phase II
- Status last verified
- Feb 2023
- First submitted
- 18 Jan 2022
- Last updated
- 7 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 36905161
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation Therapy for Recovery of Hospital-acquired Weakness in Critically Ill COVID-19 Patients - A Proof of Concept Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05198466
- Acronym / sponsor ID
- Phase II / H-47781-B
- Conditions
- COVID-19, Muscle Atrophy, Muscle Weakness
- Keywords
- Electrical Stimulation, Skin perfusion, Muscle dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Avazzia, Inc
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Posted 18 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active E-Stim | Active comparator | Device: Electrical StimulationSubjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). |
| Electrical Stimulation - Sham | Sham comparator | Device: Electrical Stimulation - ShamSubjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Post-COVID-19 patients who required hospitalization due to COVID-19 severe infection.
- Post-COVID-19 patients who required hospitalization and present neuromuscular sequelae due to COVID-19 severe infection.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical StimulationSubjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). | Device | Active E-Stim |
| Electrical Stimulation - ShamSubjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). | Device | Electrical Stimulation - Sham |
Primary outcome
Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation
Time frame: an average of 4 weeks (Phase II)
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).
Ankle Strength
Time frame: an average of 4 weeks (phase II).
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).
1 secondary outcome
Plantar Oxyhemoglobin
Time frame: an average of 4 weeks (phase II)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36905161Zulbaran-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Electrical Stimulation in people with COVID-19 and Muscle Atrophy, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation (time frame: an average of 4 weeks (Phase II)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05198466, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.