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Behavioural Intervention

tDCS for Cognitive Impairment

N/A

Waitlist Available

Led By Aprinda I Queen, PhD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 60-95 years

Be older than 18 years old

Must not have

Inability to communicate in English

Incidence of stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 minutes versus 24 minutes in each session. then comparing active versus sham stimulation sessions, separated by at least two weeks.

Summary

"This trial is looking at how using transcranial direct current stimulation (tDCS) can improve memory in older adults with mild memory problems compared to those with normal memory."

Who is the study for?

This trial is for older adults with mild cognitive impairments (MCI), which means they have some memory or thinking problems but can still do their daily activities. It's not clear who can't join because the exclusion criteria are missing.

What is being tested?

The study is testing if a non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS) can improve working memory in people with MCI. Participants will be randomly assigned to receive either active tDCS or a placebo-like sham tDCS.

What are the potential side effects?

tDCS is generally considered safe, but side effects may include mild itching, tingling, or discomfort at the site of application; headache; fatigue; and nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 60 and 95 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot communicate in English.

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I have had a stroke.

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I have a history of brain injuries or mental health disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 minutes versus 24 minutes in each session. then comparing active versus sham stimulation sessions, separated by at least two weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 minutes versus 24 minutes in each session. then comparing active versus sham stimulation sessions, separated by at least two weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 minutes versus 24 minutes in each session. then comparing active versus sham stimulation sessions, separated by at least two weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

2-back Working Memory Accuracy

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tDCSExperimental Treatment1 Intervention

A neuroConn MR-safe 1x1 tDCS stimulator will be used to apply 12 minutes of 2.0 mA electrical current, with 30 seconds ramps up and 30 seconds ramps down. The electrical current will be applied by using two carbon rubber electrodes (one anode, one cathode) with added ten20 conductive paste. The electrode+paste will be affixed on the participant's scalp over the frontal cortices at F3 and F4 location (EEG 10-20 system). Inflow of current (anode) will occur at F4 location, and outflow of current will occur at F3 (cathode). For each stimulation condition (active, sham), each participant will perform two runs of N-back working memory task (baseline/pre-stimulation and during stimulation). Sham efficacy will be evaluated as a direct comparison in N-back performance and connectivity results in active group versus sham group.

Group II: Sham tDCSPlacebo Group1 Intervention

Sham stimulation will be performed with the same 1x1 device. Participants will receive 2 mA of direct current stimulation for 30 seconds with 30 seconds ramps up and down. This provides the tingling and prickling sensation on the scalp associated with tDCS while prevent delivering sufficient current (12 minutes) to penetrate the skull and stimulate the brain. Prep in sham conditions will be identical to active stimulation conditions. For each stimulation condition (active, sham), each participant will perform two runs of N-back working memory task (baseline/pre-stimulation and during stimulation). Sham efficacy will be evaluated as a direct comparison in N-back performance and connectivity results in active group versus sham group.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active tDCS

2012

Completed Phase 1

~1190

0 / 4Eligibility criteria met