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| Name | Class |
|---|---|
| Avazzia, Inc | INDUSTRY |
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Post-intensive care syndrome (PICS) encompasses persistent physical, cognitive, and psychiatric symptoms following ICU discharge, commonly triggered by serious conditions such as respiratory failure, sepsis, and mechanical ventilation. PICS prevalence is reported to be as high as 84% up to 12 months in patients with at least 2 days spent in the ICU or with mechanical ventilatory support. As a consequence, many patients do not return to they former level of function for weeks, months and even years.
Muscular affection manifested by muscle weakness is particularly seen and is provoked by a combination of damage to the nerves or directly the muscles fibers. This affection is referred to as CU-Acquired Weakness (ICUAW). One third of the time, lower extremities are affected, often due to prolonged immobilization or sedation. Evidence suggests that early mobilization reduces the incidence of ICUAW at discharge and improves the number of patients able of stand. However achieving this early intervention is not always feasible due to time or personnel constraints.
The purpose of the study is to examine the effectiveness of lower extremity neuromodulation for prevention of muscle deconditioning in patients admitted to the ICU.
The purpose of the study is to examine feasibility and acceptability of lower extremity neuromodulation in patients at risk of ICUAW. This is a proof Randomized controlled trial (RCT) study for prevention. Eligible participants will be recruited from Baylor St Luke's Medical Center (Houston, Texas).
Participants will be randomized to intervention group (IG) or control group (CG). The entire cohort will receive daily neuromodulation in the lower extremity (Gastrocnemius muscle, Achilles tendon) up to 1 hour. The therapy will be provided with a neuromodulation device (Tennant Biomodulator PRO®, AVAZZIA, Inc.) that works on high voltage alternative pulsed current. The device will be functional for the IG and non-functional for the CG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Active Comparator | Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first. |
|
| Control group | Sham Comparator | Subjects will receive a non-functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Group | Device | Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrocnemius Muscle Endurance at Endpoint | Gastrocnemius muscle endurance was assessed by measuring sustained involuntary muscle contractions using surface electromyography (sEMG; Delsys Trigno). During a 60-minute electrical stimulation therapy session, sEMG signals were recorded from the last two minutes of the therapy to evaluate muscle activity in response to electrical stimulation. The recorded sEMG data were normalized to the average sEMG signals captured during the same interval, yielding values in normalized units (n.u.), higher values indicate higher muscle endurance. The endpoint was defined as either the last day in the hospital or the completion of week 4 of the intervention, whichever occurred first. | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gastrocnemius Muscle Thickness at 4 Weeks Compared to Baseline | The thickness of the medial gastrocnemius muscle was measured using a portable muscle ultrasound device (Vscan Air). Changes in gastrocnemius thickness (measured in cm) from baseline to the endpoint were calculated, and the average change was reported. The endpoint was defined as either the last day in the hospital or the completion of week 4 of the intervention, whichever occurred first |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Level 4 Weeks After Hospital Discharge | Anxiety levels will be measured using the Beck anxiety inventory validated questionnaire. The minimum score is 0, meaning low anxiety, and the maximum score is 63 , meaning potential concerning levels of anxiety. | 1 month after study termination (up to 8 weeks). |
| Independence Activities of Daily Living (ADL) 4 Weeks After Hospital Discharge |
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 | Result | 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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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first. Intervention Group: Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first. |
| FG001 | Control Group | Subjects will receive a non-functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first. Control Group: Subjects will receive a non-functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first. Intervention Group: Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 at Endpoint | Gastrocnemius muscle endurance was assessed by measuring sustained involuntary muscle contractions using surface electromyography (sEMG; Delsys Trigno). During a 60-minute electrical stimulation therapy session, sEMG signals were recorded from the last two minutes of the therapy to evaluate muscle activity in response to electrical stimulation. The recorded sEMG data were normalized to the average sEMG signals captured during the same interval, yielding values in normalized units (n.u.), higher values indicate higher muscle endurance. The endpoint was defined as either the last day in the hospital or the completion of week 4 of the intervention, whichever occurred first. | Lung transplant recipients | Posted | Mean | Standard Deviation | n.u. | Up to 4 weeks |
|
up to 8 weeks post initiation of intervention.
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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 | Intervention | Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first. |
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Limitations:
EMG reading can be affected by variation in skin conductivity. Factors such as dry skin, sweat, edema, can alter electrical conductivity of skin, potentially leaidng to some inacurracies in readings.
Muscle ultrasound: Highly user dependence. Also limitations exist when this modality is used for repeated measurments. Ensuring position and location of the probe during each scan is challenging and can result in measurment variablity.
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 9, 2023 | Nov 14, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 17, 2024 | Jul 25, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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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 neuromodulation in lower extremity (e.g. Gastronemius muscle) for up to 1 hour. The neuromodulation device will be functional for IG and non-functional for CG.
Phase I will include patients admitted to the Intensive care Unit. The study duration will be 4 weeks or until hospital discharge, whichever comes first.
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Devices may be active or sham.
| Control Group | Device | Subjects will receive a non-functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first. |
|
| Up to 4 weeks |
| Percentage of Tissue Oxygen Saturation at Endpoint | Percentage of tissue oxygen saturation was measured at endpoint (study conclusion) at three time points: before neuromodulation (minute 0), immediately after 1 hour of neuromodulation (minute 60), and 10 minutes post-neuromodulation (minute 70) at the plantar region, following the protocol described by Zurbaran-Rojas et al. (Physiological Reports, 2023, DOI: 10.14814/phy2.15636). A non-invasive near-infrared spectroscopy camera (Snapshot, Kent Imaging) will be used to obtain oxygen saturation in response to neuromodulation. The endpoint was defined as either the last day in the hospital or up to week 4 of the intervention, whichever came first. | up to 4 weeks |
| Ankle Strength at 4 Weeks | Maximum Voluntary Contraction will be assed using a dynamometer during isometric plantar flexion for 5 seconds. | up to 4 weeks |
| Sural Nerve Conduction at 4 Weeks | Sural nerve conduction will be assessed using the DPN check device (Neurometrix Inc). | up to 4 weeks. |
| Sural Nerve Amplitude at 4 Weeks | Sural nerve amplitude will be assessed using the DPN check device (Neurometrix Inc). | up to 4 weeks. |
Independence activities of daily living will be measured using Katz Index Scale . The minimum score is 0, meaning patient independent, and the maximum score is 6, meaning patient very dependent. |
| 1 month after study termination (up to 8 weeks). |
| Instrumental Activities of Daily Living (IADL) 4 Weeks After Hospital Discharge | Independence in Instrumental activities of daily living will be measured Lawton Brody Scale . The minimum score is 0, meaning low function-dependent, and the maximum score is 8, meaning high function independent. | 1 month after study termination (up to 8 weeks). |
| Individuals Mobility and Participation in Various Life Spaces or Environments | Individuals functional mobility and extent of community engagement will be measured with the UAB life space questionnaire. The minimum score is 0, totally bed-bound, and the maximum score is 120, meaning traveling everyday out of town without assistance. | 1 month after study termination (up to 8 weeks). |
| Deep Vein Thrombosis Events at 4 Weeks | The incidence of deep vein thrombosis was documented from electronic health records at week 4 following the initiation of the intervention. | 4 weeks |
| BG001 |
| Control |
Subjects will receive a non-functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first. Control Group: Subjects will receive a non-functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| High Blood Pressure | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Former Smoker | Count of Participants | Participants |
|
| OG001 | Control Group | Subjects will receive a non-functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first. Control Group: Subjects will receive a non-functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first. |
|
|
| Secondary | Change in Gastrocnemius Muscle Thickness at 4 Weeks Compared to Baseline | The thickness of the medial gastrocnemius muscle was measured using a portable muscle ultrasound device (Vscan Air). Changes in gastrocnemius thickness (measured in cm) from baseline to the endpoint were calculated, and the average change was reported. The endpoint was defined as either the last day in the hospital or the completion of week 4 of the intervention, whichever occurred first | Posted | Mean | Standard Deviation | centimeters | Up to 4 weeks |
|
|
|
| Secondary | Percentage of Tissue Oxygen Saturation at Endpoint | Percentage of tissue oxygen saturation was measured at endpoint (study conclusion) at three time points: before neuromodulation (minute 0), immediately after 1 hour of neuromodulation (minute 60), and 10 minutes post-neuromodulation (minute 70) at the plantar region, following the protocol described by Zurbaran-Rojas et al. (Physiological Reports, 2023, DOI: 10.14814/phy2.15636). A non-invasive near-infrared spectroscopy camera (Snapshot, Kent Imaging) will be used to obtain oxygen saturation in response to neuromodulation. The endpoint was defined as either the last day in the hospital or up to week 4 of the intervention, whichever came first. | This secondary outcome for one of the subjects in the intervention group was not collected due to time constraints. | Posted | Mean | Standard Deviation | Percentage of tissue oxygen saturation | up to 4 weeks |
|
|
|
| Secondary | Ankle Strength at 4 Weeks | Maximum Voluntary Contraction will be assed using a dynamometer during isometric plantar flexion for 5 seconds. | This secondary outcome was not collected for all participants due to time constraints or participants' inability to complete the test. | Posted | Mean | Standard Deviation | kg | up to 4 weeks |
|
|
|
| Secondary | Sural Nerve Conduction at 4 Weeks | Sural nerve conduction will be assessed using the DPN check device (Neurometrix Inc). | This secondary outcome was not collected for all participants due to time constraints. | Posted | Mean | Standard Deviation | m/s | up to 4 weeks. |
|
|
|
| Secondary | Sural Nerve Amplitude at 4 Weeks | Sural nerve amplitude will be assessed using the DPN check device (Neurometrix Inc). | Posted | Mean | Standard Deviation | microvolts (µV). | up to 4 weeks. |
|
|
|
| Other Pre-specified | Anxiety Level 4 Weeks After Hospital Discharge | Anxiety levels will be measured using the Beck anxiety inventory validated questionnaire. The minimum score is 0, meaning low anxiety, and the maximum score is 63 , meaning potential concerning levels of anxiety. | Posted | Median | Full Range | score on a scale | 1 month after study termination (up to 8 weeks). |
|
|
|
| Other Pre-specified | Independence Activities of Daily Living (ADL) 4 Weeks After Hospital Discharge | Independence activities of daily living will be measured using Katz Index Scale . The minimum score is 0, meaning patient independent, and the maximum score is 6, meaning patient very dependent. | Posted | Median | Full Range | score on a scale | 1 month after study termination (up to 8 weeks). |
|
|
|
| Other Pre-specified | Instrumental Activities of Daily Living (IADL) 4 Weeks After Hospital Discharge | Independence in Instrumental activities of daily living will be measured Lawton Brody Scale . The minimum score is 0, meaning low function-dependent, and the maximum score is 8, meaning high function independent. | Posted | Median | Full Range | score on a scale | 1 month after study termination (up to 8 weeks). |
|
|
|
| Other Pre-specified | Individuals Mobility and Participation in Various Life Spaces or Environments | Individuals functional mobility and extent of community engagement will be measured with the UAB life space questionnaire. The minimum score is 0, totally bed-bound, and the maximum score is 120, meaning traveling everyday out of town without assistance. | Posted | Median | Full Range | score on a scale | 1 month after study termination (up to 8 weeks). |
|
|
|
| Other Pre-specified | Deep Vein Thrombosis Events at 4 Weeks | The incidence of deep vein thrombosis was documented from electronic health records at week 4 following the initiation of the intervention. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Control | Subjects will receive a non-functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first. | 0 | 13 | 0 | 13 | 0 | 13 |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |
| D008722 | Methods |
| Plantar Sat02 at 70 minutes |
|