Non-Invasive Brain Stimulation and Delirium

NCT03518996 | Withdrawn FDA Device

• 1 other identifier: 201803846
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorders; Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Delirium Observation Screening (DOS) Scale

  During the 1 week of treatment, with follow up 1 week

• Delirium Rating Scale-R-98 (DRS)

  During the 1 week of treatment, with follow up 1 week

• Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)

  During the 1 week of treatment, with follow up 1 week

Study Arms (2)

TMS/tACS

EXPERIMENTAL

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

Sham TMS/tACS

SHAM COMPARATOR

Subjects will receive 5 days of 3x daily sham stimulation of the cerebellum.

Device: Sham TMS/tACS

Interventions

rTMS/iTBS/tACS DEVICE

Subjects with delirium and matched-controls will be receive theta frequency stimulation of the cerebellum. We will target the cerebellar vermis.

TMS/tACS

Sham TMS/tACS DEVICE

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

Also known as: Sham stimulation

Sham TMS/tACS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gen Shinozaki: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (14)

• 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.

  PMID: 19347026 BACKGROUND

• 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.

  PMID: 23992774 BACKGROUND

• Inouye SK. Delirium in older persons. N Engl J Med. 2006 Mar 16;354(11):1157-65. doi: 10.1056/NEJMra052321. No abstract available.

  PMID: 16540616 BACKGROUND

• 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.

  PMID: 2240918 BACKGROUND

• 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.

  PMID: 11730446 BACKGROUND

• 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.

  PMID: 22669559 BACKGROUND

• 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.

  PMID: 19632604 BACKGROUND

• 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.

  PMID: 7864702 BACKGROUND

• 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.

  PMID: 22305529 BACKGROUND

• 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.

  PMID: 27518561 BACKGROUND

• 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.

  PMID: 23130833 BACKGROUND

• 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.

  PMID: 19680444 BACKGROUND

• 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.

  PMID: 24034465 BACKGROUND

• 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.

  PMID: 15893410 BACKGROUND

MeSH Terms

Conditions

Mental Disorders; Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders

Study Officials

• Gen Shinozaki, MD, MS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 8, 2018
• Study Start: September 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

US (1)