Transcranial Direct Current Stimulation for the Treatment of Delirium

NCT03256500 | Unknown

• 1 other identifier: IRB201400807
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Delirium is induced by changes in cortical excitability and transcranial direct current stimulation (tDCS), by using weak electrical fields, can modulate cortical excitability and spontaneous firing activities in the stimulated region by shifting the resting membrane. One half of the subjects will receive stimulation via tDCS and the other half will receive sham tDCS for 20 minutes per day, 5 days per week, for 1 week. Symptoms will be monitored using the Confusion Assessment Method.

Conditions

Delirium; Confusion

Outcome Measures

Primary Outcomes (1)

• Reduction in signs and symptoms of delirium

  Negative screens for delirium for at least 48 hours

  Time points at which the measurement will be done is within 5 minutes to an hour after procedure and another one will be done 4 to 5 hours later.

Study Arms (2)

tDCS administered

EXPERIMENTAL

Subjects will receive stimulation via tDCS (Transcranial Direct Current Stimulation) for 20 minutes per day, 5 days per week, for 1 week.

Device: Transcranial Direct Current Stimulation

Sham tDCS administered

SHAM COMPARATOR

Subjects will receive sham tDCS (Transcranial Direct Current Stimulation) for 20 minutes per day, 5 days per week, for 1 week.

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

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 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.

Also known as: tDCS

Sham tDCS administered; tDCS administered

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with presence of delirium, confirmed by "Confusion Assessment Method". Age \> 21 years old Hospitalized at the Malcom Randall Veterans Affairs Hospital. Number of patients who will be recruited: 100

You may not qualify if:

• Patients with agitation. Pregnancy Patents with a history of epilepsy or have evidence of epilepsy on their EEG. Implanted devices anywhere in the body Unstable medical conditions like uncontrolled Diabetes, Hypertension Unconscious patients

Sponsors & Collaborators

• North Florida/South Georgia Veterans Health System: lead

Study Sites (1)

Malcolm Randall Veterans Affairs Medical Center

Gainesville, Florida, 32608, United States

RECRUITING

MeSH Terms

Conditions

Delirium; Confusion

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Uma Suryadevara, MD

  Malcom Randall VAMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uma Suryadevara, MD

CONTACT

352-548-6000; uma.suryadevara@va.gov

Colleen Campbell

CONTACT

352-376-1611; colleen.campbell@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: August 22, 2017
• Study Start: September 1, 2016
• Primary Completion: December 30, 2019
• Study Completion: June 30, 2020
• Last Updated: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)