Transcranial Direct Current Stimulation for the Treatment of Delirium

Hospitalized patients with delirium, who are over age 21, will be the subjects for this research study. This will include both men and women at the Malcom Randall Veterans Affairs Hospital. The presence of delirium will be determined by the "Confusion Assessment Method (CAM)" which is a standardized evidence-based tool that enables clinicians to identify patients who are suffering with delirium. The CAM and the CAM-ICU have been reported to have a sensitivity of 94-100% with a specificity of 89-95%, together with a high inter-rater reliability (Wei, Fearing, Eliezer, Sternberg, & Inouye, 2008).

Patients with agitation at the moment of the procedure, pregnancy or patients with history of epilepsy or show evidence of epilepsy on their EEG will be excluded.

As part of their routine medical care all participants will be fully evaluated for the possible causes of delirium including: neurological disorders (CT or MRI, EEG, possible LP); failure of vital organs (cardiac, hepatic, renal, pulmonary), metabolic disorders (e.g. abnormalities of blood chemistries), endocrine disorders (e.g., abnormal thyroid function tests), infections (e.g., urinary, pulmonary, sepsis), toxins-drugs-medications, and deficiency states (B1, B12, etc). These conditions will be treated accordingly by their primary provider. There will be no change in the rest of the care that the patient will get when they get hospitalized.

Because patients with delirium lack the capacity to consent, the consent will be obtained from a legally authorized representative who is usually the spouse, adult child, a relative or a close friend. The legally authorized representative or guardian advocate who can make decisions on the patient's behalf, will be appointed by the legal authorities. They can be a health care surrogate/agent appointed by the person in a Durable Power of Attorney for Health Care (DPAHC) or similar document. The legally authorized representative can also be a court appointed guardian. If the patient/patient's legal representative decides to participate in the study, the Principal Investigator will collect private information about the patient's health, which is called Protected Health Information (PHI). The protected health information will be then be coded and each subject will be given a unique identification number before entering it into the password protected folder on the server. Once eligibility is determined, the information is obtained from the medical records regarding psychiatric disorders, neurological conditions, cardiac conditions, current medications, study results, age < 89 in numerical values, sex, education level and details regarding any tests or procedures done.

A neurocognitive assessment will be done on all the patients identified as potential subjects for the study. The assessment will be done by Uma Suryadevara, Colleen Campbell, Ronald Shorr, Kenneth Heilman, Laurence Solberg, Andrew Pierce or Joseph Thornton. After the assessment is done, subjects are assigned into two groups, one group that gets the sham and group that gets the real treatment. One half of the subjects will receive sham and the other half will receive tDCS. The Soterix Medical 1x1 line of low-intensity tDCS stimulators which we plan to use is designed to generate low levels of direct current between one anode and one cathode placed on the body. The current enters the body through the positive electrode, the anode exits the body through the negative electrode, the cathode. The accessories provided with the device allow for simple and comfortable positioning of the electrodes on the body. The procedure will be done by Uma Suryadevara who went through the training and is certified and Colleen Campbell will activate the sham in some patients. Laurence Solberg, Ronald shorr, Andrew Pierce and Joseph Thornton will do the procedure after being trained. Adam Woods is the expert in tDCS and has been teaching this procedure for sometime now and will help us with the process. The transcranial Direct Current Stimulator has the option of activating or deactivating the 'sham'. All participants will be treated with sham or real tDCS for 20 minutes per day, 5 days per week, for 1 week during their hospitalization. The person performing the neurocognitive assessment will be unaware if the participant is receiving sham or tDCS. The electrodes will be placed over the left and right frontal lobes, near the dorsolateral prefrontal cortex, (anode on the left and cathode on the right) using the International 10-20 system as a guide for electrode placement. (Poreisz et al., 2007; Nitsche et al, 2012. tDCS utilizes either two saline-soaked sponge or electrode gel coated electrodes affixed to the scalp, which causes a weak electrical current. The maximum output of the current is 2 milliamp and each electrode has an area of 25-35 cm^2. For stimulation in the experimental condition, a current of 1.0-2.0 milliamps will be used, which is gradually increased and decreased to achieve this target current over 30 seconds. Vitals will be taken before and after tDCS treatments. Both before stimulation and after stimulation on each day, as well as daily one week after stimulation, subjects will undergo an assessment for change in symptoms using the Memorial Delirium Assessment Scale (MDAS). Since the effects of the stimulation may last for a short time post stimulation testing will begin approximately 5 minutes after the stimulation and be completed within one hour. Testing will also be done one more time later that afternoon to measure the change in symptoms.