Non-Invasive Brain Stimulation and Delirium

Delirium Clinical Trial

Official title:

Non-Invasive Brain Stimulation and Delirium

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03518996
• Other study ID #: 201803846
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2021
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Mental Disorders

Intervention

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 TMS/tACS
Subjects with delirium and matched-controls will be receive sham stimulation of the cerebellum. We will target the cerebellar vermis.

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Gen Shinozaki

Country where clinical trial is conducted

United States, 

References & Publications (14)

Barrientos RM, Higgins EA, Biedenkapp JC, Sprunger DB, Wright-Hardesty KJ, Watkins LR, Rudy JW, Maier SF. Peripheral infection and aging interact to impair hippocampal memory consolidation. Neurobiol Aging. 2006 May;27(5):723-32. — View Citation

Christensen BC, Houseman EA, Marsit CJ, Zheng S, Wrensch MR, Wiemels JL, Nelson HH, Karagas MR, Padbury JF, Bueno R, Sugarbaker DJ, Yeh RF, Wiencke JK, Kelsey KT. Aging and environmental exposures alter tissue-specific DNA methylation dependent upon CpG island context. PLoS Genet. 2009 Aug;5(8):e1000602. doi: 10.1371/journal.pgen.1000602. Epub 2009 Aug 14. — View Citation

Day K, Waite LL, Thalacker-Mercer A, West A, Bamman MM, Brooks JD, Myers RM, Absher D. Differential DNA methylation with age displays both common and dynamic features across human tissues that are influenced by CpG landscape. Genome Biol. 2013;14(9):R102. — View Citation

Dyer CB, Ashton CM, Teasdale TA. Postoperative delirium. A review of 80 primary data-collection studies. Arch Intern Med. 1995 Mar 13;155(5):461-5. Review. — View Citation

Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. — View Citation

Flinn DR, Diehl KM, Seyfried LS, Malani PN. Prevention, diagnosis, and management of postoperative delirium in older adults. J Am Coll Surg. 2009 Aug;209(2):261-8; quiz 294. doi: 10.1016/j.jamcollsurg.2009.03.008. Epub 2009 May 1. Review. — View Citation

Fong TG, Tulebaev SR, Inouye SK. Delirium in elderly adults: diagnosis, prevention and treatment. Nat Rev Neurol. 2009 Apr;5(4):210-20. doi: 10.1038/nrneurol.2009.24. Review. — View Citation

Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. — View Citation

Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28. Review. — View Citation

Inouye SK. Delirium in older persons. N Engl J Med. 2006 Mar 16;354(11):1157-65. Review. Erratum in: N Engl J Med. 2006 Apr 13;354(15):1655. — View Citation

Marcantonio ER. Postoperative delirium: a 76-year-old woman with delirium following surgery. JAMA. 2012 Jul 4;308(1):73-81. doi: 10.1001/jama.2012.6857. — View Citation

Numata S, Ye T, Hyde TM, Guitart-Navarro X, Tao R, Wininger M, Colantuoni C, Weinberger DR, Kleinman JE, Lipska BK. DNA methylation signatures in development and aging of the human prefrontal cortex. Am J Hum Genet. 2012 Feb 10;90(2):260-72. doi: 10.1016/j.ajhg.2011.12.020. Epub 2012 Feb 2. Erratum in: Am J Hum Genet. 2012 Oct 5;91(4):765. — View Citation

Sen P, Shah PP, Nativio R, Berger SL. Epigenetic Mechanisms of Longevity and Aging. Cell. 2016 Aug 11;166(4):822-839. doi: 10.1016/j.cell.2016.07.050. Review. — View Citation

Tsai PC, Spector TD, Bell JT. Using epigenome-wide association scans of DNA methylation in age-related complex human traits. Epigenomics. 2012 Oct;4(5):511-26. doi: 10.2217/epi.12.45. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in brain rhythms	Change from baseline EEG activity in participants receiving stimulation	During the 1 week of treatment, with follow up 1 week
Secondary	Delirium Observation Screening (DOS) Scale	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
Secondary	Delirium Rating Scale-R-98 (DRS)	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
Secondary	Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)	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