Non-Invasive Brain Stimulation and Delirium

July 20, 2021 updated by: Gen Shinozaki
The purpose of this study is to examine whether non-invasive brain stimulation can be used to improve cognitive deficits in patients with delirium.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • Sham stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During the 1 week of treatment, with follow up 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
During the 1 week of treatment, with follow up 1 week
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.
During the 1 week of treatment, with follow up 1 week
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.
During the 1 week of treatment, with follow up 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gen Shinozaki

Investigators

  • Principal Investigator: Gen Shinozaki, MD, MS, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

April 17, 2018

First Submitted That Met QC Criteria

April 25, 2018

First Posted (Actual)

May 8, 2018

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201803846

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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