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Non-Invasive Brain Stimulation and Delirium

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ClinicalTrials.gov Identifier: NCT03518996
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Gen Shinozaki, University of Iowa

Brief Summary:
The purpose of this study is to examine whether non-invasive brain stimulation can be used to improve cognitive deficits in patients with delirium.

Condition or disease Intervention/treatment Phase
Mental Disorders Delirium Device: rTMS/iTBS/tACS Device: Sham TMS/tACS Not Applicable

Detailed Description:

Data from subject's EPIC medical record will be abstracted for use in research analysis - the following elements will be reviewed: Information regarding diagnosis, age, gender, ethnicity/race, medication they are receiving as well as their past medical history, and DOSS score. The study team member will also discuss patient's mental status with their treating clinician before approaching him/her. The treating clinician will be consulted and must agree that it is appropriate for the delirious patient to be approached for enrollment. Beforehand, a clinician on the research team (Dr. Gen Shinozaki) will evaluate the subjects ability to sign consent, and thus, whether they can be approached for enrollment.

When subject is identified, consent team will approach to obtain consent (and assent when applicable), email address and research demographic information. If consented, subject undergo a short CAM-ICU assessment of delirium indication - the CAM-ICU is a delirium screening tool and is not done for screening individuals out of the study, a cognitive function evaluation (MoCA), Clinical Dementia Rating (CDR), and a longer delirium evaluation (DRS-R-98) conducted by a study team member.

Next, study personnel will obtain buccal swab samples and will assist with saliva samples. Trained medical staff will perform the blood draw for the blood collection sample, approximately 5-10 mL of blood per sample will be collected. If consented, subject will be asked to wear non-invasive EEG device (with two standard, clinical leads) on their head at the time of initial evaluation and up to two times daily during their hospital stay. What subjects will be asked to do/what happens in the study (in sequential order) if they meet inclusion criteria and consent, they will be asked to wear non-invasive EEG device (with two standard, clinical leads) on their head with EEG monitor capability up to three times daily while they are in the hospital.

One session of non-invasive brain stimulation will be administered. Study personnel will again obtain buccal swab samples and will assist with saliva samples. Trained research team members will perform the blood draw for the blood collection sample, approximately 5-10 mL of blood per sample will be collected.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Non-Invasive Brain Stimulation and Delirium
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: TMS/tACS
Subjects will receive 5 days of 3x daily rTMS (intermittent theta burst stimulation) or tACS (transcranial alternating current stimulation) targeted over the cerebellum.
Device: rTMS/iTBS/tACS
Subjects with delirium and matched-controls will be receive theta frequency stimulation of the cerebellum. We will target the cerebellar vermis.

Sham Comparator: Sham TMS/tACS
Subjects will receive 5 days of 3x daily sham stimulation of the cerebellum.
Device: Sham TMS/tACS
Subjects with delirium and matched-controls will be receive sham stimulation of the cerebellum. We will target the cerebellar vermis.
Other Name: Sham stimulation




Primary Outcome Measures :
  1. Change in brain rhythms [ Time Frame: During the 1 week of treatment, with follow up 1 week ]
    Change from baseline EEG activity in participants receiving stimulation


Secondary Outcome Measures :
  1. Delirium Observation Screening (DOS) Scale [ Time Frame: During the 1 week of treatment, with follow up 1 week ]
    Change between pre- and post-intervention DOS assessment (disease-specific symptom rating scale); The Delirium Observation Screening (DOS) Scale is a screen designed to allow faster, easier identification of delirium. The DOS is a 13-point screen for delirium (range 0-9). Higher values represent a worse outcome (scores greater than or equal to 3 are usually considered positive delirium screens).

  2. Delirium Rating Scale-R-98 (DRS) [ Time Frame: During the 1 week of treatment, with follow up 1 week ]

    Change between pre- and post-intervention DRS assessment (disease-specific symptom rating scale); The Delirium Rating-Scale-Revised-98 (DRS-R-98) is an instrument which has provision for assessment of broad range of symptoms of delirium. The instrument has a total range of 0-20.

    The severity ratings range from 0 (no impairment) to 3 (severe impairment) and a severity score > 15 or a total score of > 18 is indicative of delirium; higher scores indicate higher severity of delirium.


  3. Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) [ Time Frame: During the 1 week of treatment, with follow up 1 week ]
    Change between pre- and post-intervention CAM-ICU assessment; Confusion Assessment Method for the ICU (CAM-ICU). CAM-ICU is a valid and reliable delirium assessment tool recommended by the Society of Critical Care Medicine (SCCM) in its 2013 Pain, Agitation, and Delirium (PAD) guidelines.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A clinical diagnosis consistent with enrollment (positive for delirium)

Exclusion Criteria:

  • History of recurrent seizures or epilepsy
  • Any other neurological or psychiatric diagnosis outside the diagnosis for which the participant is enrolled.
  • Active substance use disorder in the past 6 months other than tobacco use disorder.
  • Pacemaker
  • Coronary Stent
  • Defibrillator
  • Neurostimulation
  • Claustrophobia
  • Uncontrolled high blood pressure
  • Atrial fibrillation
  • Significant heart disease
  • Hemodynamic instability
  • Kidney disease
  • Pregnant, trying to become pregnant, or breast feeding

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): NCT03518996


Contacts
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Contact: Gen Shinozaki, MD, MS (319) 384-4932 gen-shinozaki@uiowa.edu
Contact: Kasra Zarei, MS (319) 430-0869 kasra-zarei@uiowa.edu

Locations
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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Kasra Zarei, MS         
Sponsors and Collaborators
Gen Shinozaki
Investigators
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Principal Investigator: Gen Shinozaki, MD, MS University of Iowa

Publications:

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Responsible Party: Gen Shinozaki, Associate Professor of Psychiatry, University of Iowa
ClinicalTrials.gov Identifier: NCT03518996     History of Changes
Other Study ID Numbers: 201803846
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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.: Yes
Additional relevant MeSH terms:
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Delirium
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders