ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 396 for:    Neuromuscular | Recruiting, Not yet recruiting, Available Studies | "Muscular Diseases"

Neurosciences-Intensive Care Unit Electrical Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03547687
Recruitment Status : Not yet recruiting
First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Michelle Cameron, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Intensive Care (ICU) Myopathy Device: Electrical Stimulation Treatment Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electrical Stimulation to Reduce Length of Stay and Duration of Intubation in the Neurosciences-intensive Care Unit (NSICU)
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: 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.
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

Other Names:
  • Intelect Neuromuscular Electrical Stimulator (NMES)
  • Intelect Portable Electrotherapy for NMES




Primary Outcome Measures :
  1. Duration of intubation [ Time Frame: Within 90 days ]
    Duration of intubation in days


Secondary Outcome Measures :
  1. Length of NSICU stay [ Time Frame: Within 90 days ]
    Calculated based on date of admission to NSICU and date of transfer from NSICU

  2. Length of hospital stay [ Time Frame: Within 90 days ]
    Calculated based on date of admission to hospital and date of discharge from hospital

  3. Modified Rankin Scale [ Time Frame: Within 90 days ]
    Modified Rankin Scale 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.

  4. Glasgow Outcome Scale - Extended [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547687


Contacts
Contact: Holly Hinson, MD, MCR 503-494-8311 hinson@ohsu.edu
Contact: Emma Rickles 503-349-3644 rickles@ohsu.edu

Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Michelle Cameron, MD, PT, MCR Oregon Health and Science University

Responsible Party: Michelle Cameron, Associate Professor of Neurology, School of Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03547687     History of Changes
Other Study ID Numbers: STUDY00018079
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Michelle Cameron, Oregon Health and Science University:
Electrical stimulation
Intubation
ICU discharge