SMART Stimulation: Precision Neuromodulation of Cognition in Older Adults

The current study will investigate methods for enhancing cognitive training (CT) effects in healthy older adults by employing a combination of interventions facilitating neural plasticity and optimizing readiness for learning. A pilot randomized clinical trial will examine the individual and combined impact of pairing cognitive training with transcranial direct current stimulation (tDCS). A precision dosing algorithm will be used to determine the appropriate levels of current and location of electrodes to deliver current using tDCS.

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Key information

Conditions

Aging

Age range

65 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McKnight Brain Institute

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Men and women
Age: 65 to 89 years
English speaking
Physically mobile
Working memory function between 0-75th percentile determined by screening results on the POSIT Baseline Cognitive Training computerized tasks.

Exclusion criteria

Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury).
Evidence of dementia (NACC UDS scores of 1.5 standard deviations below the mean for age, sex and education adjusted norms in a single cognitive domain on the task).
Past opportunistic brain infection
Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis or severe major depression and/or suicidality.
Unstable (e.g., cancer other than basal cell skin) and chronic (e.g, severe diabetes) medical conditions.
MRI contraindications (e.g., pregnancy, claustrophobia, metal implants that are contraindicated for MRI).
Physical impairment precluding motor response or lying still for 1 hr and inability to walk two blocks without stopping.
Certain prescription medications may possibly reduce effects otherwise induced by the tDCS stimulation protocol.
Hearing or vision deficits that will not allow for standardized cognitive training stimulation; ie colorblindness, inability to hear through headphones (with or without hearing aids), macular degeneration or other significant diseases that cause severe loss of vision. If vision is corrected with lenses to appropriate levels, then participant will be eligible.
Left handedness, as those with left-handedness have a higher percentage rate of atypical functional lateralization for brain functions, which would significantly interfere with interpretability of brain data.
Participants with precision tDCS dosage of >4.0mA required will be excluded due to limitations of tDCS device (maximum output of 4.0 mA). The maximum output of 4.0 mA reflects a technical limitation of the device design rather than a safety threshold.

Treatment and study plan

tDCS

Device

During tDCS, a weak electrical current is applied to the scalp that penetrates skin, bone, CSF and the meninges to stimulate underlying cortical and subcortical tissue

Cognitive training

Behavioral

Cognitive Training (CT) will involve up to 10 hours of training over 2-weeks (10 days). CT employs a PositScience BrainHQ suite via its researcher portal. These tasks are web-based and multi-platform (i.e., Windows, Mac). Participants will be randomly assigned to training on 4 tasks focusing on working memory or 4 tasks focusing on attention/speed of processing.

Primary outcomes

N-Back Working Memory

Time frame: Baseline to post test. Post test will occur approximately two weeks following baseline.

Change in working memory performance on the N back working memory MRI task from baseline to post test will be assessed. Post test will occur approximately two weeks following baseline.

The N-back working memory task will be completed during the MRI scan at both baseline and post test assessments. Working memory performance will be defined as a composite of reaction time and accuracy for two back trials. Specifically Target Accuracy percent correct and average correct target reaction time in milliseconds. Percent changes were calculated for Target Accuracy and Reaction Time in the form of (post test-pre test)/pre test. Since the direction of improvement is opposite for the two variables (i.e. higher Accuracy is better and lower Reaction Time is better), the reaction time percent change was multiplied by -1 to ensure a larger number indicated improved performance. To create a composite these two percent changes (Target Accuracy and Reaction Time) were averaged into a single value.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

Soterix Medical

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: May 17, 2022
Registry last updated: Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed