Neurosciences-Intensive Care Unit Electrical Stimulation

NCT03547687 | Completed Results FDA Device

• 1 other identifier: STUDY00018079
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Electrical stimulation; Intubation; ICU discharge

Outcome Measures

Primary Outcomes (1)

• Duration of Intubation

  Duration of intubation in days

  Within 90 days

Secondary Outcomes (4)

• Length of Neuroscience Intensive Care Unit Stay

  Within 90 days

• Length of Hospital Stay

  Within 90 days

• Modified Rankin Scale

  Within 90 days

• Glasgow Outcome Scale - Extended

  Within 90 days

Study Arms (1)

Electrical Stimulation Treatment

EXPERIMENTAL

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.

Device: Electrical Stimulation Treatment; Device: Neuromuscular Electrical Stimulation Treatment

Interventions

Electrical Stimulation Treatment DEVICE

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

Also known as: Intelect Neuromuscular Electrical Stimulator (NMES), Intelect Portable Electrotherapy for NMES

Electrical Stimulation Treatment

Neuromuscular Electrical Stimulation Treatment DEVICE

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

Also known as: Vectra Neo Clinical Therapy System

Electrical Stimulation Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission to the NSICU for care for a neurologic illness requiring critical care
• Mechanically ventilated at time of enrollment
• Prognosis for prolonged ICU stay and/or prolonged intubation as evidenced by at least one pre-morbid risk factor: age ≥ 65 years, major medical co-morbidity (ex: heart failure, chronic obstructive pulmonary disease, chronic renal insufficiency, diabetes, poorly controlled hypertension, etc.), or severe acute critical illness (APACHE II \>12)

You may not qualify if:

• Contraindications to electrical stimulation - demand cardiac pacemaker, implanted cardiac defibrillator, deep brain stimulator, adhesive allergy, pregnancy
• Agitation such that the individual is at risk for pulling off the self-adhesive electrodes
• Moribund prognosis (not expected to survive \>48 hours, initiation of comfort measures only)
• Severe peripheral edema
• Receiving vasopressors at the time of enrollment, or hemodynamically unstable
• Severe peripheral neuropathy (ex: acute inflammatory polyneuropathy)
• Receiving paralytic drug(s)

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Muscular Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Limitations and Caveats

We were unable to achieve consistent muscle contraction with the initial portable NMES device. No patients were enrolled for 5 months while another clinical NMES device that had a higher maximum intensity output was obtained. More patients likely qualified than were actually enrolled, as screening and enrollment were limited by study staff availability. Small number of subjects enrolled lead to uninterpretable analysis of historic controls.

Results Point of Contact

• Title: Dr. Julia Durrant
• Organization: Oregon Health Science University

durrantj@ohsu.edu

503-494-0353

Study Officials

• Michelle Cameron, MD, PT, MCR

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology, School of Medicine

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 6, 2018
• Study Start: August 10, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 24, 2021
• Results First Posted: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)