Trial Outcomes & Findings for Neurosciences-Intensive Care Unit Electrical Stimulation (NCT NCT03547687)

NCT ID: NCT03547687

Last Updated: 2021-02-24

Results Overview

Duration of intubation in days

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: Within 90 days
• Results posted on: 2021-02-24

Participant Flow

Patients admitted to the Neuro ICU were screened for eligibility through a review of medical records in Epic by study staff, and approached for consent. Patients with prognosticated prolonged stay were approached on day 2 to 5 of their ICU stay for enrollment. If patients had reversible exclusion criteria, such as hemodynamic instability or elevated intracranial pressures, they were rescreened daily for potential enrollment until day 7.

Participant milestones

Measure	Electrical Stimulation Treatment Patient will receive electrical stimulation to the quadriceps muscle groups on both lower extremities simultaneously for 45 minutes at a time, for a total of 5 treatments each week (Mon-Sun), for up to 14 days or until ICU discharge, whichever comes first. Electrical Stimulation Treatment: An Intelect Neuromuscular Electrical Stimulator (NMES) (Chattanooga Group) device or a Vectra® Neo Clinical Therapy System will be used to provide the stimulation. The stimulator will be set up and taken off the patients by a member of the study team or a trained ICU staff member. The stimulation parameters will be as follows: Electrode location: Proximal and distal quadriceps Waveform: pulsed biphasic Pulse duration: 300-450 microseconds Pulse frequency: 35 pulses per second Amplitude: palpable, visible quadriceps muscle contraction On/off time: 10 seconds on, 30 seconds off Ramp up and down time: 2 seconds each
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Electrical Stimulation Treatment Patient will receive electrical stimulation to the quadriceps muscle groups on both lower extremities simultaneously for 45 minutes at a time, for a total of 5 treatments each week (Mon-Sun), for up to 14 days or until ICU discharge, whichever comes first. Electrical Stimulation Treatment: An Intelect Neuromuscular Electrical Stimulator (NMES) (Chattanooga Group) device or a Vectra® Neo Clinical Therapy System will be used to provide the stimulation. The stimulator will be set up and taken off the patients by a member of the study team or a trained ICU staff member. The stimulation parameters will be as follows: Electrode location: Proximal and distal quadriceps Waveform: pulsed biphasic Pulse duration: 300-450 microseconds Pulse frequency: 35 pulses per second Amplitude: palpable, visible quadriceps muscle contraction On/off time: 10 seconds on, 30 seconds off Ramp up and down time: 2 seconds each
Overall Study Withdrawal by Subject	1
Overall Study Death	1

Baseline Characteristics

Neurosciences-Intensive Care Unit Electrical Stimulation

Baseline characteristics by cohort

Measure	Electrical Stimulation Treatment n=9 Participants Patient will receive electrical stimulation to the quadriceps muscle groups on both lower extremities simultaneously for 45 minutes at a time, for a total of 5 treatments each week (Mon-Sun), for up to 14 days or until ICU discharge, whichever comes first. Electrical Stimulation Treatment: An Intelect Neuromuscular Electrical Stimulator (NMES) (Chattanooga Group) device or a Vectra® Neo Clinical Therapy System will be used to provide the stimulation. The stimulator will be set up and taken off the patients by a member of the study team or a trained ICU staff member. The stimulation parameters will be as follows: Electrode location: Proximal and distal quadriceps Waveform: pulsed biphasic Pulse duration: 300-450 microseconds Pulse frequency: 35 pulses per second Amplitude: palpable, visible quadriceps muscle contraction On/off time: 10 seconds on, 30 seconds off Ramp up and down time: 2 seconds each
Age, Continuous	55.7 years STANDARD_DEVIATION 21.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants
Weight	74.5 kilograms STANDARD_DEVIATION 18.6 • n=5 Participants
BMI	28.49 kg/m2 STANDARD_DEVIATION 6.22 • n=5 Participants
SOFA Score	6.56 units on a scale STANDARD_DEVIATION 2.46 • n=5 Participants
APACHE II Score	18.67 units on a scale STANDARD_DEVIATION 3.57 • n=5 Participants

PRIMARY outcome

Timeframe: Within 90 days

Duration of intubation in days

Outcome measures

Measure

Electrical Stimulation Treatment n=9 Participants Patient will receive electrical stimulation to the quadriceps muscle groups on both lower extremities simultaneously for 45 minutes at a time, for a total of 5 treatments each week (Mon-Sun), for up to 14 days or until ICU discharge, whichever comes first. Electrical Stimulation Treatment: An Intelect Neuromuscular Electrical Stimulator (NMES) (Chattanooga Group) device or a Vectra® Neo Clinical Therapy System will be used to provide the stimulation. The stimulator will be set up and taken off the patients by a member of the study team or a trained ICU staff member. The stimulation parameters will be as follows: Electrode location: Proximal and distal quadriceps Waveform: pulsed biphasic Pulse duration: 300-450 microseconds Pulse frequency: 35 pulses per second Amplitude: palpable, visible quadriceps muscle contraction On/off time: 10 seconds on, 30 seconds off Ramp up and down time: 2 seconds each

Duration of Intubation

10.22 days Standard Deviation 10.44

SECONDARY outcome

Timeframe: Within 90 days

Calculated based on date of admission to Neuroscience Intensive Care Unit (NSICU) and date of transfer from NSICU

Outcome measures

Measure

Electrical Stimulation Treatment n=9 Participants Patient will receive electrical stimulation to the quadriceps muscle groups on both lower extremities simultaneously for 45 minutes at a time, for a total of 5 treatments each week (Mon-Sun), for up to 14 days or until ICU discharge, whichever comes first. Electrical Stimulation Treatment: An Intelect Neuromuscular Electrical Stimulator (NMES) (Chattanooga Group) device or a Vectra® Neo Clinical Therapy System will be used to provide the stimulation. The stimulator will be set up and taken off the patients by a member of the study team or a trained ICU staff member. The stimulation parameters will be as follows: Electrode location: Proximal and distal quadriceps Waveform: pulsed biphasic Pulse duration: 300-450 microseconds Pulse frequency: 35 pulses per second Amplitude: palpable, visible quadriceps muscle contraction On/off time: 10 seconds on, 30 seconds off Ramp up and down time: 2 seconds each

Length of Neuroscience Intensive Care Unit Stay

13.67 days Standard Deviation 6.58

SECONDARY outcome

Timeframe: Within 90 days

Calculated based on date of admission to hospital and date of discharge from hospital

Outcome measures

Measure

Electrical Stimulation Treatment n=9 Participants Patient will receive electrical stimulation to the quadriceps muscle groups on both lower extremities simultaneously for 45 minutes at a time, for a total of 5 treatments each week (Mon-Sun), for up to 14 days or until ICU discharge, whichever comes first. Electrical Stimulation Treatment: An Intelect Neuromuscular Electrical Stimulator (NMES) (Chattanooga Group) device or a Vectra® Neo Clinical Therapy System will be used to provide the stimulation. The stimulator will be set up and taken off the patients by a member of the study team or a trained ICU staff member. The stimulation parameters will be as follows: Electrode location: Proximal and distal quadriceps Waveform: pulsed biphasic Pulse duration: 300-450 microseconds Pulse frequency: 35 pulses per second Amplitude: palpable, visible quadriceps muscle contraction On/off time: 10 seconds on, 30 seconds off Ramp up and down time: 2 seconds each

Length of Hospital Stay

29.56 days Standard Deviation 24.17

SECONDARY outcome

Timeframe: Within 90 days

Modified Rankin Scale at at NSICU transfer, assessed by Nurse Practitioner. Measures degree of disability in patients after neurologic injury. Scale range is 0-6, higher value is a worse outcome.

Outcome measures

Measure

Electrical Stimulation Treatment n=9 Participants Patient will receive electrical stimulation to the quadriceps muscle groups on both lower extremities simultaneously for 45 minutes at a time, for a total of 5 treatments each week (Mon-Sun), for up to 14 days or until ICU discharge, whichever comes first. Electrical Stimulation Treatment: An Intelect Neuromuscular Electrical Stimulator (NMES) (Chattanooga Group) device or a Vectra® Neo Clinical Therapy System will be used to provide the stimulation. The stimulator will be set up and taken off the patients by a member of the study team or a trained ICU staff member. The stimulation parameters will be as follows: Electrode location: Proximal and distal quadriceps Waveform: pulsed biphasic Pulse duration: 300-450 microseconds Pulse frequency: 35 pulses per second Amplitude: palpable, visible quadriceps muscle contraction On/off time: 10 seconds on, 30 seconds off Ramp up and down time: 2 seconds each

Modified Rankin Scale

4.33 score on a scale Standard Deviation 1.73

SECONDARY outcome

Timeframe: Within 90 days

Glasgow Outcome Scale - Extended at NSICU transfer, assessed by Nurse Practitioner. Measures global functional outcomes after neurologic injury. Scale range is 1-8, higher value is a better outcome.

Outcome measures

Measure

Electrical Stimulation Treatment n=9 Participants Patient will receive electrical stimulation to the quadriceps muscle groups on both lower extremities simultaneously for 45 minutes at a time, for a total of 5 treatments each week (Mon-Sun), for up to 14 days or until ICU discharge, whichever comes first. Electrical Stimulation Treatment: An Intelect Neuromuscular Electrical Stimulator (NMES) (Chattanooga Group) device or a Vectra® Neo Clinical Therapy System will be used to provide the stimulation. The stimulator will be set up and taken off the patients by a member of the study team or a trained ICU staff member. The stimulation parameters will be as follows: Electrode location: Proximal and distal quadriceps Waveform: pulsed biphasic Pulse duration: 300-450 microseconds Pulse frequency: 35 pulses per second Amplitude: palpable, visible quadriceps muscle contraction On/off time: 10 seconds on, 30 seconds off Ramp up and down time: 2 seconds each

Glasgow Outcome Scale - Extended

3.44 score on a scale Standard Deviation 2.55

Adverse Events

Electrical Stimulation Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Julia Durrant

Oregon Health Science University

Phone: 503-494-0353

Email: durrantj@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place