Recruiting

Transcranial Direct Current Stimulation

Sponsor:

North Florida/South Georgia Veterans Health System

Code:

NCT03256500

Conditions

Delirium

Confusion

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcranial Direct Current Stimulation

Study Details

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

Study ID

NCT03256500

Start date

Sep, 2016

Status verified date

Aug, 2018

Completion date

Jun 30, 2020

Anticipated

Primary completion date

Dec 30, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: tDCS administered

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

sham comparator: Sham tDCS administered

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

Interventions

Transcranial Direct Current Stimulation

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.

Primary outcome measure

  • Reduction in signs and symptoms of delirium [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Uma Suryadevara, MD

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

Colleen Campbell

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

Locations

Malcolm Randall Veterans Affairs Medical Center

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Colleen Campbell

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

Principal Investigator:

Uma Suryadevara, M.D

More Information

Sponsor

North Florida/South Georgia Veterans Health System

Last update posted

Aug 7, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by North Florida/South Georgia Veterans Health System on 2018-08-07.