Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-09-01
2022-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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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.
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 will receive 5 days of 3x daily sham stimulation of the cerebellum.
Sham TMS/tACS
Subjects with delirium and matched-controls will be receive sham stimulation of the cerebellum. We will target the cerebellar vermis.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
90 Years
ALL
Yes
Sponsors
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Gen Shinozaki
OTHER
Responsible Party
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Gen Shinozaki
Associate Professor of Psychiatry
Principal Investigators
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Gen Shinozaki, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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University of Iowa
Iowa City, Iowa, United States
Countries
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References
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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.
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.
Inouye SK. Delirium in older persons. N Engl J Med. 2006 Mar 16;354(11):1157-65. doi: 10.1056/NEJMra052321. No abstract available.
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. doi: 10.7326/0003-4819-113-12-941.
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. doi: 10.1001/jama.286.21.2703.
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.
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. No abstract available.
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. doi: 10.1001/archinte.155.5.461.
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.
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.
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.
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.
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. doi: 10.1186/gb-2013-14-9-r102.
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. doi: 10.1016/j.neurobiolaging.2005.03.010.
Other Identifiers
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201803846
Identifier Type: -
Identifier Source: org_study_id
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