What side effects are associated with this type of intervention?

Common treatments for aging that involve neuromodulation, such as Transcranial Direct Current Stimulation (tDCS) and Transcranial Magnetic Stimulation (TMS), generally have mild side effects. For tDCS, side effects may include a tingling sensation, itching, redness at the site of electrode placement, and mild headache. TMS can cause scalp discomfort, mild headache, and in rare cases, seizures, particularly in individuals with epilepsy. Both treatments are considered non-invasive and have a favorable safety profile, with serious adverse events being uncommon.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for aging that are directly comparable to transcranial direct current stimulation (tDCS). tDCS is a non-invasive neuromodulation technique being studied for its potential to enhance cognitive function and neural plasticity in older adults. While there are FDA-approved neuromodulation devices for other conditions, such as transcranial magnetic stimulation (TMS) for depression and vagus nerve stimulation (VNS) for epilepsy and depression, these are not specifically approved for aging. Research is ongoing to explore the benefits of tDCS and similar technologies for age-related cognitive decline.

What other types of research exist?

Promising, novel alternatives to tDCS for aging patients include: 1) Transcutaneous supraorbital nerve stimulation, which has shown efficacy in reducing migraine pain intensity. 2) Remote electrical neuromodulation, which has demonstrated significant pain relief in migraine patients. 3) Transcranial magnetic stimulation (TMS), which has been effective in treating migraine with aura and may also enhance cognitive function. 4) Noninvasive vagus nerve stimulation (nVNS), which may benefit acute treatment of episodic migraine.

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tDCS + Cognitive Training for Aging

N/A

Waitlist Available

Research Sponsored by University of Florida

Eligibility Criteria Checklist

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

Must have

Physically mobile

Age: 65 to 89 years

Must not have

Past opportunistic brain infection

Physical impairment precluding motor response or lying still for 1 hr and inability to walk two blocks without stopping

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to post test. post test will occur approximately two weeks following baseline.

Summary

This trial aims to improve mental exercises for older adults by using a combination of brain training activities and mild electrical stimulation. The electrical stimulation is applied through electrodes on the scalp to make the brain more adaptable and ready to learn. Researchers will use a special algorithm to determine the best settings for the electrical current.

Who is the study for?

This trial is for healthy older adults aged 65 to 89 who are physically mobile, have working memory function in the lower three-quarters percentile, and can understand English. Exclusions include severe physical or neurological impairments, psychiatric illnesses, MRI contraindications like metal implants, unstable medical conditions, certain medications that interfere with tDCS effects, left-handedness due to brain lateralization concerns, and significant hearing or vision deficits.

What is being tested?

The study tests how cognitive training (CT) can be improved when combined with transcranial direct current stimulation (tDCS) in older adults. It uses a precision dosing algorithm for tDCS to optimize neural plasticity and learning readiness by adjusting the electric current levels and electrode placement on participants' heads.

What are the potential side effects?

Potential side effects of tDCS may include mild itching or tingling at the electrode sites during application, fatigue after treatment sessions, headache or nausea. However these tend to be mild and temporary.

Eligibility Criteria

Inclusion Criteria

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

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I can move around on my own.

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I am between 65 and 89 years old.

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My working memory is within the normal range according to a computer test.

Exclusion Criteria

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

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I have had a serious brain infection in the past.

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I cannot stay still for an hour or walk two blocks without stopping due to physical issues.

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I have a neurological disorder like dementia, stroke, or seizures.

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I do not have unstable or severe chronic conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to post test. post test will occur approximately two weeks following baseline.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to post test. post test will occur approximately two weeks following baseline.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to post test. post test will occur approximately two weeks following baseline. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

N-Back working memory

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Optimized tDCS + Cognitive TrainingExperimental Treatment2 Interventions

A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of up to 4.0mA direct current through two biocarbon rubber electrodes covered with at least 5mm-thick conductive electrode paste buffer, and placed over the optimized locations based on the international 10-20 system by using a combination of 10-20 EEG cap measurement and a stereotactic neuronavigation system. Stereotactic neuronavigation will be used as needed and may not be used on all participants.

Group II: Sham tDCS + Cognitive TrainingPlacebo Group2 Interventions

Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of up to 4 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

cognitive training

2020

N/A

~650

tDCS

2017

Completed Phase 2

~630

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for aging, such as Transcranial Direct Current Stimulation (tDCS), work by modulating neuronal activity to enhance neural plasticity. This is crucial for aging patients as it can improve cognitive functions, such as memory and processing speed, which often decline with age. By promoting neural plasticity, these treatments help maintain brain health and functionality, potentially delaying the onset of age-related cognitive impairments and improving overall quality of life.