Neurosciences-Intensive Care Unit Electrical Stimulation

Summary

Patients admitted to the Neurosciences Intensive Care Unit (NSICU) are at particular risk of developing ICU-associated weakness and myopathy, given the unique risks of early mobilization in these patients, which include increased intracranial pressure, hemodynamic instability, vasospasm, decreased cerebral blood flow with resultant cerebral ischemia, and delirium. Interventions that could provide some of the benefits of early mobilization without these risks would be of great utility in the NSICU. A number of studies have demonstrated that electrical stimulation of the lower extremity muscles, generally the quadriceps, can retard disuse atrophy and loss of strength associated with medical ICU stays, and one study has shown reduced length of intubation and accelerated functional recovery. This pilot trial will evaluate the impact of electrical stimulation on patients in the NSICU, with a hypothesis that electrical stimulation treatments will reduce the length of hospital stay and intubation and improve functional recovery. In this trial, intubated patients admitted to the NSICU will have electrical stimulation applied to the quadriceps muscle groups on both lower extremities simultaneously for 45 minutes at a time for a total of 5 treatments each week, for up to 14 days or until ICU discharge, whichever comes first.

Conditions

• Intensive Care (ICU) Myopathy

Interventions

DEVICE

Electrical Stimulation Treatment

An Intelect Neuromuscular Electrical Stimulator (NMES) (Chattanooga Group) device 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 microseconds Pulse frequency: 35 pulses per second Amplitude: palpable, visible quadriceps muscle contraction On/off time: 5 seconds on, 15 seconds off Ramp up and down time: 2 seconds each

DEVICE

Neuromuscular Electrical Stimulation Treatment

If a muscle contraction is not produced with the Intelect NMES portable device, the Vectra Neo Clinical Therapy System (Chattanooga Group) device will be used instead. 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 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

Sponsors & Collaborators

• Oregon Health and Science University

  lead OTHER

Principal Investigators

• Michelle Cameron, MD, PT, MCR · Oregon Health and Science University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-10

Primary Completion

2019-12-31

Completion

2019-12-31

FDA Device

Yes

Countries

• United States

Study Locations