Non-Invasive Brain Stimulation and Delirium



Status:Recruiting
Conditions:Neurology, Psychiatric, Psychiatric, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 90
Updated:4/6/2019
Start Date:September 1, 2018
End Date:December 1, 2022
Contact:Gen Shinozaki, MD, MS
Email:gen-shinozaki@uiowa.edu
Phone:(319) 384-4932

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

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.

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
We found this trial at
1
site
101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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