AgingNCT05377411
SMART Stimulation: Precision Neuromodulation of Cognition in Older Adults
A study testing tDCS and cognitive training in people with Aging, run by University of Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- tDCS and cognitive training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2023to 3 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
McKnight Brain Institute
Gainesville, Florida, 32610
About this study
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.
- Conditions
- Aging
- Being tested
- tDCS, cognitive training
- Keywords
- tdcs, cognitive training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Optimized tDCS + Cognitive Training | Experimental | 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. Receives: Device: tDCS; Behavioral: cognitive training |
| Sham tDCS + Cognitive Training | Sham comparator | 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. Receives: Device: tDCS; Behavioral: cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-Back Working Memory
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.
Measured: Baseline to post test. Post test will occur approximately two weeks following baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start17 Jan 2023
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Arm 1 will receive optimized tDCS paired with cognitive training. Arm 2 will receive sham tDCS paired with cognitive training.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Soterix Medical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377411
- Sponsor's protocol ID
- IRB202100953
- Status last verified
- Oct 2024
- First submitted
- 7 Apr 2022
- Last updated
- 26 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART Stimulation: Precision Neuromodulation of Cognition in Older Adults
- ClinicalTrials.gov ID
- NCT05377411
- Acronym / sponsor ID
- IRB202100953
- Conditions
- Aging
- Keywords
- tdcs, cognitive training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Soterix Medical
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Posted 26 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Arm 1 will receive optimized tDCS paired with cognitive training. Arm 2 will receive sham tDCS paired with cognitive training.
| Arm | Type | Receives |
|---|---|---|
| Optimized tDCS + Cognitive Training | Experimental | Device: tDCS, Behavioral: cognitive trainingA 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. |
| Sham tDCS + Cognitive Training | Sham comparator | Device: tDCS, Behavioral: cognitive trainingSham 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. |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSDuring 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 | Device | Optimized tDCS + Cognitive Training, Sham tDCS + Cognitive Training |
| cognitive trainingCognitive 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. | Behavioural | Optimized tDCS + Cognitive Training, Sham tDCS + Cognitive Training |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and cognitive training in people with Aging, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N-Back Working Memory (time frame: Baseline to post test. Post test will occur approximately two weeks following baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.