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Device
tDCS administered for Delirium
N/A
Waitlist Available
Led By Uma Suryadevara, MD
Research Sponsored by North Florida/South Georgia Veterans Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
Study 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.
Eligible Conditions
- Delirium
- Confusion
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction in signs and symptoms of delirium
Side effects data
From 2021 Phase 2 & 3 trial • 160 Patients • NCT024834682%
Car accident
2%
skin irritation
100%
80%
60%
40%
20%
0%
Study treatment Arm
tDCS (Active)
tDCS (Sham)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: tDCS administeredExperimental Treatment1 Intervention
Subjects will receive stimulation via tDCS (Transcranial Direct Current Stimulation) for 20 minutes per day, 5 days per week, for 1 week.
Group II: Sham tDCS administeredPlacebo Group1 Intervention
Subjects will receive sham tDCS (Transcranial Direct Current Stimulation) for 20 minutes per day, 5 days per week, for 1 week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Direct Current Stimulation
2014
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
North Florida/South Georgia Veterans Health SystemLead Sponsor
7 Previous Clinical Trials
1,885 Total Patients Enrolled
Uma Suryadevara, MDPrincipal InvestigatorMalcom Randall VAMC
1 Previous Clinical Trials
14 Total Patients Enrolled
Frequently Asked Questions
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