Trial Outcomes & Findings for Neuromodulation for Prevention of Intensive Care Unit Acquired Weakness and Post Intensive Care Syndrome (NCT 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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

25 participants

Primary outcome timeframe

Up to 4 weeks

Results posted on

2024-12-30

Participant Flow

Participant milestones

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

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=5 Participants	59.4 years STANDARD_DEVIATION 9.5 • n=7 Participants	57.7 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	13 participants n=7 Participants	25 participants n=5 Participants
Body Mass Index	26.6 kg/m^2 STANDARD_DEVIATION 3.7 • n=5 Participants	23.8 kg/m^2 STANDARD_DEVIATION 5.3 • n=7 Participants	25.1 kg/m^2 STANDARD_DEVIATION 4.82 • n=5 Participants
High Blood Pressure	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Diabetes	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Former Smoker	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 weeks

Population: Lung transplant recipients

Outcome measures

Outcome measures
Measure	Intervention Group 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 Group 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.
Gastrocnemius Muscle Endurance at Endpoint	180 n.u. Standard Deviation 12.6	178 n.u. Standard Deviation 14.6

SECONDARY outcome

Timeframe: Up to 4 weeks

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

Outcome measures

Outcome measures
Measure	Intervention Group 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 Group 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.
Change in Gastrocnemius Muscle Thickness at 4 Weeks Compared to Baseline	-0.12 centimeters Standard Deviation 0.10	-0.17 centimeters Standard Deviation .14

SECONDARY outcome

Timeframe: up to 4 weeks

Population: 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

Outcome measures
Measure	Intervention Group 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. 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 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.
Percentage of Tissue Oxygen Saturation at Endpoint Plantar Sat02 at 0 minutes	60.2 Percentage of tissue oxygen saturation Standard Deviation 7.9	64.1 Percentage of tissue oxygen saturation Standard Deviation 8.3
Percentage of Tissue Oxygen Saturation at Endpoint Plantar Sat02 at 60 minutes	58 Percentage of tissue oxygen saturation Standard Deviation 6.7	64.1 Percentage of tissue oxygen saturation Standard Deviation 9.0
Percentage of Tissue Oxygen Saturation at Endpoint Plantar Sat02 at 70 minutes	59 Percentage of tissue oxygen saturation Standard Deviation 6.1	63.8 Percentage of tissue oxygen saturation Standard Deviation 7.9

SECONDARY outcome

Timeframe: up to 4 weeks

Population: 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

Outcome measures
Measure	Intervention Group 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. 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 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. 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.
Ankle Strength at 4 Weeks	2.28 kg Standard Deviation .69	2.15 kg Standard Deviation .94

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

Outcome measures
Measure	Intervention Group 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. 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 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. 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.
Sural Nerve Conduction at 4 Weeks	50.5 m/s Standard Deviation 6.3	47.15 m/s Standard Deviation 8.2

SECONDARY outcome

Timeframe: up to 4 weeks.

Sural nerve amplitude will be assessed using the DPN check device (Neurometrix Inc).

Outcome measures

Outcome measures
Measure	Intervention Group 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. 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 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. 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.
Sural Nerve Amplitude at 4 Weeks	10 microvolts (µV). Standard Deviation 5.3	6.9 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

Outcome measures
Measure	Intervention Group 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. 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 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. 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.
Anxiety Level 4 Weeks After Hospital Discharge	4.0 score on a scale Interval 1.0 to 11.0	5.5 score on a scale Interval 2.0 to 21.0

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

Outcome measures
Measure	Intervention Group 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. 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 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. 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.
Independence Activities of Daily Living (ADL) 4 Weeks After Hospital Discharge	6.0 score on a scale Interval 0.0 to 6.0	5.0 score on a scale Interval 2.0 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

Outcome measures
Measure	Intervention Group 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. 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 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. 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.
Instrumental Activities of Daily Living (IADL) 4 Weeks After Hospital Discharge	5.5 score on a scale Interval 0.0 to 7.0	2.0 score on a scale Interval 1.0 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

Outcome measures
Measure	Intervention Group 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. 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 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. 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.
Individuals Mobility and Participation in Various Life Spaces or Environments	40.8 score on a scale Interval 0.0 to 72.0	21.0 score on a scale Interval 0.0 to 64.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

The incidence of deep vein thrombosis was documented from electronic health records at week 4 following the initiation of the intervention.

Outcome measures

Outcome measures
Measure	Intervention Group 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 Group 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.
Deep Vein Thrombosis Events at 4 Weeks	0 Participants	0 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Bijan Najafi

Baylor College of Medicine

Phone: 7137987536

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place