110 Participants Needed

tDCS for Cognitive Impairment

(AIM Trial)

AI
AI
Overseen ByAprinda I Queen, PhD

What You Need to Know Before You Apply

What is the purpose of this trial?

The current study is a mechanistic study to evaluate working memory gains from application of transcranial direct current stimulation (tDCS) in older adults with mild cognitive impairments (MCI) compared to cognitively healthy control

Will I have to stop taking my current medications?

If you are currently taking GABAergic or glutamatergic medications, or calcium or sodium channel blockers, you will need to stop, as these medications interfere with the study.

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with no serious adverse effects reported in over 33,200 sessions and 1,000 subjects, including vulnerable populations. Common side effects are mild and temporary, such as itching, tingling, and headaches.12345

How is the treatment tDCS different from other treatments for cognitive impairment?

Transcranial Direct Current Stimulation (tDCS) is unique because it is a noninvasive method that uses a mild electrical current to stimulate the brain, unlike traditional drug treatments. It is being explored for its potential to improve cognitive function in conditions like Alzheimer's disease and mild cognitive impairment without the use of medication.678910

What data supports the effectiveness of the treatment tDCS for cognitive impairment?

Research suggests that transcranial direct current stimulation (tDCS) may help improve cognitive functions like memory and processing speed in conditions such as Alzheimer's disease and mild cognitive impairment. However, the evidence is not yet strong enough to make definitive conclusions, and more large-scale studies are needed to confirm its effectiveness.6781011

Who Is on the Research Team?

AI

Aprinda I Queen, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for older adults aged 60-95 with mild cognitive impairments (MCI). Participants must be able to attend training sessions, receive electrical stimulation, understand conversational voices, and have the motor skills to use a computer mouse. A Montreal Cognitive Assessment score of 18 or above is required.

Inclusion Criteria

I can use a computer mouse and click buttons without help.
Able to receive electrical stimulation
I am between 60 and 95 years old.
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Exclusion Criteria

Terminal illness with life expectancy less than 12 months, as determined by physician
I have a brain tumor or a foreign object in my brain.
Contraindications to MRI recording (e.g., any kind of ferrous metallic stents or ferrous metal objects in the body, heart valve prosthesis, or other metal implants, claustrophobia, neurostimulation system, defibrillator, pacemaker, or other implanted device)
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham tDCS stimulation to evaluate working memory gains

12 minutes per session, with sessions separated by at least two weeks
3 visits (in-person) per stimulation condition

Follow-up

Participants are monitored for changes in working memory performance and brain connectivity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • tDCS
Trial Overview The AIM Pilot Study is testing whether transcranial direct current stimulation (tDCS) can improve working memory in older adults with MCI. The study compares active tDCS against sham tDCS (a placebo-like treatment) to see if there's a real benefit from the intervention.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCSExperimental Treatment1 Intervention
Group II: Sham tDCSPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) is a safe and noninvasive method that shows promise in treating cognitive decline associated with Alzheimer's disease and mild cognitive impairment.
The review highlights the need for further large-scale clinical trials to better understand the mechanisms of tDCS and improve its application in clinical settings.
Potential of Transcranial Direct Current Stimulation in Alzheimer's Disease: Optimizing Trials Toward Clinical Use.Pilloni, G., Charvet, LE., Bikson, M., et al.[2022]
Anodal transcranial direct current stimulation (tDCS) significantly improved cognitive performance in healthy elderly individuals by increasing neural activity, as evidenced by enhanced P200 and P300 amplitudes during a working memory task.
Cathodal tDCS also showed potential benefits for Alzheimer's disease patients, increasing P200 amplitude and frontal theta activity, suggesting that tDCS can modulate neural function differently based on the individual's cognitive state.
Behavioural and electrophysiological modulations induced by transcranial direct current stimulation in healthy elderly and Alzheimer's disease patients: A pilot study.Cespón, J., Rodella, C., Miniussi, C., et al.[2020]
Anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex significantly improved cognitive tasks related to processing speed, selective attention, and planning in five older adults with mild cognitive impairment (MCI).
The study suggests that combining tDCS with cognitive stimulation programs may enhance cognitive performance in individuals with MCI, but further research is needed to explore long-term effects and practical applications in daily life.
The Effects of Transcranial Direct Current Stimulation on the Cognitive Functions in Older Adults with Mild Cognitive Impairment: A Pilot Study.Cruz Gonzalez, P., Fong, KNK., Brown, T.[2022]

Citations

Potential of Transcranial Direct Current Stimulation in Alzheimer's Disease: Optimizing Trials Toward Clinical Use. [2022]
Behavioural and electrophysiological modulations induced by transcranial direct current stimulation in healthy elderly and Alzheimer's disease patients: A pilot study. [2020]
The Effects of Transcranial Direct Current Stimulation on the Cognitive Functions in Older Adults with Mild Cognitive Impairment: A Pilot Study. [2022]
Transcranial Direct Current Stimulation and Cognition in Neuropsychiatric Disorders: Systematic Review of the Evidence and Future Directions. [2022]
Effects of multisession transcranial direct current stimulation as an augmentation to cognitive tasks in patients with neurocognitive disorders in Japan: a study protocol for a randomised controlled trial. [2021]
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]
Safety of transcranial direct current stimulation in healthy participants. [2021]
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]
Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]
A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]
Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot Study. [2022]
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