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Transcranial Direct Current Stimulation for the Treatment of Delirium

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ClinicalTrials.gov Identifier: NCT03256500
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
North Florida/South Georgia Veterans Health System

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.

Condition or disease Intervention/treatment Phase
Delirium Confusion Device: Transcranial Direct Current Stimulation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation for the Treatment of Delirium
Study Start Date : September 2016
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
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.
Device: 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.
Other Name: tDCS

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.
Device: 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.
Other Name: tDCS




Primary Outcome Measures :
  1. 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. ]
    Negative screens for delirium for at least 48 hours



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Ages Eligible for Study:   21 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256500


Contacts
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Contact: Uma Suryadevara, MD 352-548-6000 ext 1454 uma.suryadevara@va.gov
Contact: Colleen Campbell 352-376-1611 ext 6114 colleen.campbell@va.gov

Locations
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United States, Florida
Malcolm Randall Veterans Affairs Medical Center Recruiting
Gainesville, Florida, United States, 32608
Contact: Uma Suryadevara, MD         
Contact: Colleen Campbell    352-376-1611 ext 6114    colleen.campbell@va.gov   
Principal Investigator: Uma Suryadevara, M.D         
Sub-Investigator: Colleen Campbell         
Sub-Investigator: Kenneth Heilman, M.D         
Sub-Investigator: Ronald Shorr, M.D         
Sub-Investigator: Joseph Thornton, M.D         
Sub-Investigator: Laurence Solberg, M.D         
Sub-Investigator: Adam Woods, Ph.D         
Sub-Investigator: Andrew Pierce, M.D         
Sponsors and Collaborators
North Florida/South Georgia Veterans Health System
Investigators
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Principal Investigator: Uma Suryadevara, MD Malcom Randall VAMC

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Responsible Party: North Florida/South Georgia Veterans Health System
ClinicalTrials.gov Identifier: NCT03256500     History of Changes
Other Study ID Numbers: IRB201400807
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available.

Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders