Trial Outcomes & Findings for Neuromodulation for Prevention of Intensive Care Unit Acquired Weakness and Post Intensive Care Syndrome (NCT NCT06238609)
NCT ID: NCT06238609
Last Updated: 2024-12-30
Results Overview
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.
ACTIVE_NOT_RECRUITING
NA
25 participants
Up to 4 weeks
2024-12-30
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neuromodulation for Prevention of Intensive Care Unit Acquired Weakness and Post Intensive Care Syndrome
Baseline characteristics by cohort
| Measure |
Intervention
n=12 Participants
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.
|
Control
n=13 Participants
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.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 11.12 • n=99 Participants
|
59.4 years
STANDARD_DEVIATION 9.5 • n=107 Participants
|
57.7 years
STANDARD_DEVIATION 10.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
13 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Body Mass Index
|
26.6 kg/m^2
STANDARD_DEVIATION 3.7 • n=99 Participants
|
23.8 kg/m^2
STANDARD_DEVIATION 5.3 • n=107 Participants
|
25.1 kg/m^2
STANDARD_DEVIATION 4.82 • n=206 Participants
|
|
High Blood Pressure
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Diabetes
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Former Smoker
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: Lung transplant recipients
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.
Outcome measures
| Measure |
Control
n=13 Participants
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.
|
Intervention
n=12 Participants
Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.
|
|---|---|---|
|
Gastrocnemius Muscle Endurance at Endpoint
|
178 n.u.
Standard Deviation 14.6
|
180 n.u.
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: Up to 4 weeksThe 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
Outcome measures
| Measure |
Control
n=13 Participants
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.
|
Intervention
n=12 Participants
Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.
|
|---|---|---|
|
Change in Gastrocnemius Muscle Thickness at 4 Weeks Compared to Baseline
|
-0.17 centimeters
Standard Deviation .14
|
-0.12 centimeters
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: up to 4 weeksPopulation: This secondary outcome for one of the subjects in the intervention group was not collected due to time constraints.
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.
Outcome measures
| Measure |
Control
n=13 Participants
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.
|
Intervention
n=11 Participants
Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.
|
|---|---|---|
|
Percentage of Tissue Oxygen Saturation at Endpoint
Plantar Sat02 at 0 minutes
|
64.1 Percentage of tissue oxygen saturation
Standard Deviation 8.3
|
60.2 Percentage of tissue oxygen saturation
Standard Deviation 7.9
|
|
Percentage of Tissue Oxygen Saturation at Endpoint
Plantar Sat02 at 60 minutes
|
64.1 Percentage of tissue oxygen saturation
Standard Deviation 9.0
|
58 Percentage of tissue oxygen saturation
Standard Deviation 6.7
|
|
Percentage of Tissue Oxygen Saturation at Endpoint
Plantar Sat02 at 70 minutes
|
63.8 Percentage of tissue oxygen saturation
Standard Deviation 7.9
|
59 Percentage of tissue oxygen saturation
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: up to 4 weeksPopulation: This secondary outcome was not collected for all participants due to time constraints or participants' inability to complete the test.
Maximum Voluntary Contraction will be assed using a dynamometer during isometric plantar flexion for 5 seconds.
Outcome measures
| Measure |
Control
n=11 Participants
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.
|
Intervention
n=10 Participants
Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.
|
|---|---|---|
|
Ankle Strength at 4 Weeks
|
2.15 kg
Standard Deviation .94
|
2.28 kg
Standard Deviation .69
|
SECONDARY outcome
Timeframe: up to 4 weeks.Population: This secondary outcome was not collected for all participants due to time constraints.
Sural nerve conduction will be assessed using the DPN check device (Neurometrix Inc).
Outcome measures
| Measure |
Control
n=8 Participants
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.
|
Intervention
n=7 Participants
Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.
|
|---|---|---|
|
Sural Nerve Conduction at 4 Weeks
|
47.15 m/s
Standard Deviation 8.2
|
50.5 m/s
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: up to 4 weeks.Sural nerve amplitude will be assessed using the DPN check device (Neurometrix Inc).
Outcome measures
| Measure |
Control
n=9 Participants
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.
|
Intervention
n=8 Participants
Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.
|
|---|---|---|
|
Sural Nerve Amplitude at 4 Weeks
|
6.9 microvolts (µV).
Standard Deviation 5.3
|
10 microvolts (µV).
Standard Deviation 5.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month after study termination (up to 8 weeks).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.
Outcome measures
| Measure |
Control
n=12 Participants
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.
|
Intervention
n=10 Participants
Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.
|
|---|---|---|
|
Anxiety Level 4 Weeks After Hospital Discharge
|
5.5 score on a scale
Interval 2.0 to 21.0
|
4.0 score on a scale
Interval 1.0 to 11.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month after study termination (up to 8 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.
Outcome measures
| Measure |
Control
n=12 Participants
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.
|
Intervention
n=10 Participants
Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.
|
|---|---|---|
|
Independence Activities of Daily Living (ADL) 4 Weeks After Hospital Discharge
|
5.0 score on a scale
Interval 2.0 to 6.0
|
6.0 score on a scale
Interval 0.0 to 6.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month after study termination (up to 8 weeks).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.
Outcome measures
| Measure |
Control
n=12 Participants
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.
|
Intervention
n=10 Participants
Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.
|
|---|---|---|
|
Instrumental Activities of Daily Living (IADL) 4 Weeks After Hospital Discharge
|
2.0 score on a scale
Interval 1.0 to 7.0
|
5.5 score on a scale
Interval 0.0 to 7.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month after study termination (up to 8 weeks).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.
Outcome measures
| Measure |
Control
n=11 Participants
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.
|
Intervention
n=10 Participants
Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.
|
|---|---|---|
|
Individuals Mobility and Participation in Various Life Spaces or Environments
|
21.0 score on a scale
Interval 0.0 to 64.0
|
40.8 score on a scale
Interval 0.0 to 72.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeksThe incidence of deep vein thrombosis was documented from electronic health records at week 4 following the initiation of the intervention.
Outcome measures
| Measure |
Control
n=13 Participants
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.
|
Intervention
n=12 Participants
Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.
|
|---|---|---|
|
Deep Vein Thrombosis Events at 4 Weeks
|
0 Participants
|
0 Participants
|
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place