Healthy AgingNCT06491264
Multiparameter Optimized tES for Memory in Aging
A study testing Transcranial electrical stimulation in people with Healthy Aging, run by Medical University of South Carolina.
Trial summary
With an aging population worldwide, it is critical to develop effective interventions promoting healthy cognitive aging. Transcranial electrical stimulation (tES) is a promising but not fully realized noninvasive brain stimulation approach that could improve memory. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Transcranial electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 - 85 y.o.
- Endorse good health with no history of mental or physical illness
- Willingness to adhere to the study schedule and assessments
- Able to read consent document and provide informed consent.
- English is a first or primary fluent language.
Who cannot join
- Any current psychiatric diagnosis or current Clinical Global Impression ratings of psychiatric illness > 1
- Neurodevelopmental disorders, history of Central Nervous System (CNS) disease, concussion, overnight hospitalization, or other neurologic sequela, tumors, seizures, meningitis, encephalitis, or abnormal CT or MRI of the brain
- Any psychotropic medication is taken within 5 half-lives of procedure time
- Any head trauma resulting in loss of consciousness
- Visual impairment (except the use of glasses)
- Inability to complete cognitive testing
Show all 15Show fewer
- Active participation or plan for enrollment in another evidence-based clinical trial affecting the psychosocial function
- Repeated abuse or dependence upon drugs (excluding nicotine and caffeine) or taking medications including stimulants, modafinil, thyroid medication, or steroids
- Implanted devices/ferrous metal of any kind
- History of seizure or epilepsy, currently taking medications that lower seizure thresholds
- Claustrophobia or other conditions that would prevent the MRI assessment.
- Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term).
- Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a man capable of fathering a child before, during, and/or after participation precautions should be taken. Examples of acceptable methods of birth control for participants involved in the study include birth control pills, patches, Intrauterine Devices (IUD), condoms, sponges, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant.
- Inability to adhere to the treatment schedule.
- Inability to fit the wearable device to the user's head.
About this study
Official title: Concurrent Multiparameter Optimized Noninvasive Brain Stimulation for Working Memory in Aging
With an aging population worldwide, it is critical to develop effective interventions promoting healthy cognitive aging. Transcranial electrical stimulation (tES) is a promising but not fully realized noninvasive brain stimulation approach that could improve memory. This study investigates the behavioral and electrocortical effects of personalized tES in aging to determine whether whether optimal dosing, electrode placements, and waveforms elicit stronger responses.
Read the detailed description
With an aging population worldwide, it is critical to develop effective interventions promoting healthy cognitive aging. A key component of healthy cognition is intact working memory, an executive neural process holding information temporarily. With increasing age, working memory capacity decreases and is associated with a loss of independence, thus incentivizing the need to retain a healthy working memory capacity. In addition to facilitating healthy aging, developing a method that improves working memory could help those diagnosed with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), which is currently is the 6th leading cause of death in the US and has an annual economic burden of $305 billion.
A potential approach to improve working memory is transcranial electrical stimulation (tES), a noninvasive brain stimulation method using scalp electrodes to deliver low electrical currents of 2 milliamps (mA) over the cortical target. While some prior studies have shown that prefrontal tES can improve working memory in older adults, there are small meta-analytic effect sizes and no FDA-approved indications to date. These mixed results could be due to applying one-size-fits-all and suboptimal tES parameters. In this study, the investigators will test the effects of personalized parameters, including dosing, electrode positioning, and waveforms compared to standard tES and placebo.
- Conditions
- Healthy Aging
- Being tested
- Transcranial electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial electrical stimulationDevice
We will administer active transcranial electrical stimulation in one of the 4 active stimulation conditions and 1 sham stimulation condition.
| Study group | Role | What they receive |
|---|---|---|
| Personalized tES stimulation #1 | Experimental | tES will be applied with personalized parameters in condition #1 for approximately 20 minutes. Receives: Device: Transcranial electrical stimulation |
| Personalized tES stimulation #2 | Experimental | tES will be applied with personalized parameters in condition #2 for approximately 20 minutes. Receives: Device: Transcranial electrical stimulation |
| Personalized tES stimulation #3 | Experimental | tES will be applied with personalized parameters in condition #3 for approximately 20 minutes. Receives: Device: Transcranial electrical stimulation |
| Standard tES | Experimental | Standard tES will be applied in condition #4 for approximately 20 minutes. Receives: Device: Transcranial electrical stimulation |
| Sham tES stimulation | Sham comparator | A sham (placebo) comparison condition will be applied in condition #5 for approximately 20 minutes. Receives: Device: Transcranial electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrocortical EEG changes pre- to post-tES
Observe effects of each tES condition within each of the 5 sessions, as measured by TMS-EEG
Measured: 1 year
N-back working memory changes pre- to post-tES
Observe effects of each tES condition within each of the 5 sessions on the N-back memory task
Measured: 1 year
Secondary outcomes (1)
Rate of side effects from tES
Questionnaire regarding headache, scalp sensation, and other common side effects of tES on a scale of 0-10.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start31 Dec 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: No time to pursue this research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- In this within-subjects design, participants will each receive 5 sessions of tES in a counterbalanced order. tES will be applied using different stimulation intensities that are personalized to each person using MRI scans. tES will also have different 4 different waveforms (theta, gamma, theta-gamma ranges or none).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Caulfield, Medical University of South Carolina
- Investigators
- Kevin Caulfield, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491264
- Sponsor's protocol ID
- Pro00133951
- Status last verified
- Feb 2026
- First submitted
- 17 Apr 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Multiparameter Optimized Noninvasive Brain Stimulation for Working Memory in Aging
- ClinicalTrials.gov ID
- NCT06491264
- Acronym / sponsor ID
- Pro00133951
- Conditions
- Healthy Aging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No time to pursue this research.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With an aging population worldwide, it is critical to develop effective interventions promoting healthy cognitive aging. Transcranial electrical stimulation (tES) is a promising but not fully realized noninvasive brain stimulation approach that could improve memory. This study investigates the behavioral and electrocortical effects of personalized tES in aging to determine whether whether optimal dosing, electrode placements, and waveforms elicit stronger responses.
Detailed description
With an aging population worldwide, it is critical to develop effective interventions promoting healthy cognitive aging. A key component of healthy cognition is intact working memory, an executive neural process holding information temporarily. With increasing age, working memory capacity decreases and is associated with a loss of independence, thus incentivizing the need to retain a healthy working memory capacity. In addition to facilitating healthy aging, developing a method that improves working memory could help those diagnosed with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), which is currently is the 6th leading cause of death in the US and has an annual economic burden of $305 billion.
A potential approach to improve working memory is transcranial electrical stimulation (tES), a noninvasive brain stimulation method using scalp electrodes to deliver low electrical currents of 2 milliamps (mA) over the cortical target. While some prior studies have shown that prefrontal tES can improve working memory in older adults, there are small meta-analytic effect sizes and no FDA-approved indications to date. These mixed results could be due to applying one-size-fits-all and suboptimal tES parameters. In this study, the investigators will test the effects of personalized parameters, including dosing, electrode positioning, and waveforms compared to standard tES and placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- In this within-subjects design, participants will each receive 5 sessions of tES in a counterbalanced order. tES will be applied using different stimulation intensities that are personalized to each person using MRI scans. tES will also have different 4 different waveforms (theta, gamma, theta-gamma ranges or none).
| Arm | Type | Receives |
|---|---|---|
| Personalized tES stimulation #1 | Experimental | Device: Transcranial electrical stimulationtES will be applied with personalized parameters in condition #1 for approximately 20 minutes. |
| Personalized tES stimulation #2 | Experimental | Device: Transcranial electrical stimulationtES will be applied with personalized parameters in condition #2 for approximately 20 minutes. |
| Personalized tES stimulation #3 | Experimental | Device: Transcranial electrical stimulationtES will be applied with personalized parameters in condition #3 for approximately 20 minutes. |
| Standard tES | Experimental | Device: Transcranial electrical stimulationStandard tES will be applied in condition #4 for approximately 20 minutes. |
| Sham tES stimulation | Sham comparator | Device: Transcranial electrical stimulationA sham (placebo) comparison condition will be applied in condition #5 for approximately 20 minutes. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 50 - 85 y.o.
- Endorse good health with no history of mental or physical illness
- Willingness to adhere to the study schedule and assessments
- Able to read consent document and provide informed consent.
- English is a first or primary fluent language.
Key exclusion criteria (15 listed)
- Any current psychiatric diagnosis or current Clinical Global Impression ratings of psychiatric illness > 1
- Neurodevelopmental disorders, history of Central Nervous System (CNS) disease, concussion, overnight hospitalization, or other neurologic sequela, tumors, seizures, meningitis, encephalitis, or abnormal CT or MRI of the brain
- Any psychotropic medication is taken within 5 half-lives of procedure time
- Any head trauma resulting in loss of consciousness
- Visual impairment (except the use of glasses)
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 |
|---|---|---|
| Transcranial electrical stimulationWe will administer active transcranial electrical stimulation in one of the 4 active stimulation conditions and 1 sham stimulation condition. | Device | Personalized tES stimulation #1, Personalized tES stimulation #2, Personalized tES stimulation #3, Sham tES stimulation, Standard tES |
Primary outcome
Electrocortical EEG changes pre- to post-tES
Time frame: 1 year
Observe effects of each tES condition within each of the 5 sessions, as measured by TMS-EEG
N-back working memory changes pre- to post-tES
Time frame: 1 year
Observe effects of each tES condition within each of the 5 sessions on the N-back memory task
1 secondary outcome
Rate of side effects from tES
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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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.
Kevin Caulfield, PhD principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial electrical stimulation in people with Healthy Aging, run by Medical University of South Carolina.
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 15 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: withdrawn, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Electrocortical EEG changes pre- to post-tES (time frame: 1 year). The study lists 2 primary outcomes in all. 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 25 Feb 2026.