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Mild Cognitive Impairment (MCI)Phase 2NCT07097051

Multi-session Transcranial Alternating Current Stimulation to Improve Dual-task Standing and Brain Activity in Older Adults With Mild Cognitive Impairment

A Phase 2 study testing real tACS in people with Mild Cognitive Impairment (MCI), run by High Point University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Older adults with Mild Cognitive Impairment (MCI) often show less brain activity in a specific range (8-13 Hz, known as alpha power) compared to healthy older adults. Those with lower alpha activity, especially in the front part of the brain, usually have problems with executive functions like planning and… Read more about this study

Who is it for?
Ages 65 to 85 years
Conditions the study is for
Mild Cognitive Impairment (MCI)
What is being tested?
real tACS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
13 May 2025to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age 65+
  • Who have been diagnosed with cognitive impairment (based in MoCA or TICS and Clinical Dementia Rating: CDR 0.5)
  • Ability to stand and walk independently
  • Willing and capable to give informed consent for the participation in the study after it has been thoroughly explained
  • Cut off of MOCA score >18 will be applied
  • Able and willing to comply with all study requirements informed consent form was signed
  • Understanding of the ICF will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form (see attached). Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.

Who cannot join

  • Cut off of MOCA score <18 will be applied
  • Major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
  • Blindness or other disabilities that prevent task performance
  • Self-reported history of stroke or neurodegenerative disorders other than MCI.
  • Self-reported active cancer for which chemo-/radiation therapy is being received.
  • Contraindications to tACS, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuro-active drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • High Point University

    High Point, North Carolina, 27262

Other trials in United States

About this study

Older adults with Mild Cognitive Impairment (MCI) often show less brain activity in a specific range (8-13 Hz, known as alpha power) compared to healthy older adults. Those with lower alpha activity, especially in the front part of the brain, usually have problems with executive functions like planning and multitasking. Our research has shown that older adults with lower alpha power in these areas also struggle more with balance when they have to do two things at once (like standing and performing a cognitive task simultaneously).

The investigators believe that increasing alpha power in older adults with MCI could improve their balance and executive function, helping them stay independent longer. In early studies, the investigators found that using transcranial alternating current stimulation (tACS) at 10 Hz on the front part of the brain can boost alpha power and balance immediately after a single session in older adults with MCI. The effect was stronger in those whose natural brain activity was close to the 10 Hz stimulation.

Read more

Based on these findings, the investigators plan to conduct a pilot study with older adults aged 65-85 years with MCI. Participants will be randomly assigned to receive either real tACS or a sham (placebo) treatment. Our main hypothesis is that real tACS will improve balance when multitasking, and these improvements will last for 1 to 3 months after the treatment. The investigators also believe that tACS will enhance other aspects of executive function and mobility and that these improvements will be linked to increased alpha activity in the brain.

Through this study, we aim to gather strong evidence that tailored tACS is a promising treatment to improve cognitive and motor functions and overall brain activity in older adults with MCI.

Read the detailed description

Older adults with Mild Cognitive Impairment (MCI) exhibit reduced brain alpha power (i.e., activity fluctuations in the 8-13 Hz range) compared to healthy older adults, and older adults who exhibit lower alpha activity in the fronto-central areas tend to have impaired executive function. In addition, our group has demonstrated that older adults who exhibit lower fronto-central alpha power during dual-task standing (i.e., standing while performing an unrelated cognitive task) have worse standing balance performance. We, therefore, contend that strategies designed to increase alpha power in older adults with MCI hold promise to enhance dual-task balance and other measures of executive function, and ultimately help these vulnerable individuals maintain functional independence over time.

In our preliminary studies, we have demonstrated that a single exposure to transcranial alternating current stimulation (tACS) delivered at 10 Hz over the fronto-central regions of the brain increases alpha power and dual-task balance in older adults with MCI, when tested just after stimulation. We have also observed that in older adults with MCI, 10 Hz tACS appears to have a greater effect on alpha activity and dual-task balance in those individuals whose peak alpha frequency happens to be at or near the stimulation frequency (10 Hz).

Given the above evidence, we will conduct a pilot, double-blinded, parallel-arm, randomized controlled trial in ambulatory women and men aged 65-85 years with MCI. Our primary hypothesis is that compared to sham, tACS will improve dual-task balance when tested at the end of the intervention, and that such effects will persist at the 1- and 3-month follow-up. We further hypothesize that 1) tACS, compared to sham, will improve performance in other clinically-tractable measures of executive function and mobility, and 2) that tACS-induced improvements in dual-task balance will correlate with increased alpha brain activity. Through these efforts, we anticipate providing rigorous preliminary data that individually-tailored tACS is an effective therapeutic option capable of inducing sustained improvements in cognitive-motor functions, as well as underlying brain activity, in older adults with MCI.

Being tested
real tACS, sham tACS
Keywords
brain stimulation, balance, cognition, executive function
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • real tACSOther

    Those who randomized into real tACS arm will receive ten-session of individually tailored tACS targeting peak alpha power for 20-minutes

  • sham tACSOther

    Those who randomized into sham tACS arm will receive ten-session of active sham tACS intervention for 20-minutes

Study groups in NCT07097051
Study groupRoleWhat they receive
real tACSExperimentalThe investigators will administer the transcranial alternating current stimulation (tACS) intervention individually tailored to peak alpha power to the participants. This intervention will utilize 8 electrodes; electrode placement and current parameters for each electrode have been optimized using a standard brain to generate an average electric field of 0.25 V/m. To ensure adherence to current safety recommendations for tACS, optimizations will be constrained to a maximum of total injected current 4.0 mA and a max. current per electrode of 2.0 mA. Stimulation will start and end with a 60 s ramp up/down to maximize comfort and the entire session will take 22-minute. This standard approach is both well-tolerated and safe in older adults.
Receives: Other: real tACS
sham tACSPlacebo comparatorThe investigators will administer the sham tACS intervention to the participants. They will use an active sham in which very low-level alternating currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the session. Stimulation will start and end with a 60 s ramp up/down to maximize comfort and the entire session will last in 22-minutes.
Receives: Other: sham tACS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EEG alpha-band power

    Change of EEG oscillations and frequency coupling at 8-13 Hz

    Measured: Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment).

  2. Change of postural sway speed

    his metric assesses the ability to control standing posture

    Measured: Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment).

Secondary outcomes (10)
  1. Change of executive function score

    This metric reflects measures of executive function scores based on individual neuropsychological test of Trail-making Test B completion time

    Measured: Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment).

  2. Change of dual-task gait speed

    This metric (m/s) assesses the ability to walk and perform a cognitive task at the same time and predicts cognitive decline and the development of dementia.

    Measured: Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment).

  3. Timed Up and Go Test completion time

    This test assesses time to complete standing from a chair, walking three meters, turning around a cone and returning to a seated position in the chair.

    Measured: Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment).

  4. Short Physical Performance Battery score

    This common test assesses physical functioning. The score is ranging from 0 to 12, with higher scores indicating better physical performance.

    Measured: Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment).

  5. Montreal Cognitive Assessment (MoCA)

    This common test assesses global cognitive function. The Montreal Cognitive Assessment (MoCA) test is scored out of a total of 30 points, with higher scores indicating better cognitive function.

    Measured: Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment).

  6. Dual-task Standing Postural Sway Path

    This metric assesses the ability to stand and perform a cognitive task at the same time and predicts cognitive decline and the development of dementia.

    Measured: Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment).

  7. Serial subtraction test performance

    This metric assesses the number of correct response on serial subtraction test while standing

    Measured: Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment).

  8. Digit Span total recall

    This metric assesses working memory.

    Measured: Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment).

  9. WAIS-IV Coding test completion time

    This metric assesses sustained attention and motor speed.

    Measured: Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment).

  10. Brain networks connectivity changes

    Measures of functional brain connectivity based on resting-state functional magnetic resonance imaging.

    Measured: Baseline and immediate post-intervention assessments

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2025
  2. Study start13 May 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07097051
Sponsor's protocol ID
IRB-FY2025-70
Status last verified
Sep 2026
First submitted
21 Jul 2025
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing real tACS in people with Mild Cognitive Impairment (MCI), run by High Point University 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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

EEG alpha-band power (time frame: Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment).). 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 16 Sep 2026.

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