Mild Cognitive Impairment (MCI)TACS-MCINCT07752316
Gamma tACS to Improve Cognitive Function in Mild Cognitive Impairment
A study testing transcranial electrical stimulation in people with Mild Cognitive Impairment (MCI), run by The National Brain Mapping Laboratory (NBML) at 1 site in Iran.
Trial summary
Mild cognitive impairment (MCI) is a decline in memory and thinking that exceeds normal aging but does not substantially disrupt daily life, and it raises the risk of developing dementia. Effective treatments for its cognitive difficulties are few. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women only
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- 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
- 30 participants
- Where
- 1 siteIran
- Study dates
- 2 Mar 2024to 15 Oct 2025
- 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 60 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, aged 60 to 75 years
- Diagnosis of mild cognitive impairment (MCI) established by a psychiatrist and documented in the patient's medical record
- Montreal Cognitive Assessment (MoCA) score between 16 and 22
- Written informed consent to participate in the study
- No history of Parkinson's disease, stroke, epilepsy, schizophrenia, or congenital olfactory and gustatory disorders
Who cannot join
- Inability to tolerate the adverse effects of the stimulation
- Unwillingness to continue the sessions
- Absence from more than three intervention sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of 80 Hz Transcranial Alternating Current Stimulation (tACS) on Cognitive Function in the Elderly With Mild Cognitive Impairment
Mild cognitive impairment (MCI) is a decline in memory and thinking that exceeds normal aging but does not substantially disrupt daily life, and it raises the risk of developing dementia. Effective treatments for its cognitive difficulties are few.
This study tests whether transcranial alternating current stimulation (tACS), a non-invasive method that delivers a weak oscillating electrical current through scalp electrodes, can improve thinking and memory in older women with MCI. The current oscillates at 80 Hz, a frequency in the gamma range, because gamma brain rhythms support memory and attention and are disrupted in MCI.
Thirty older women with MCI are randomly assigned to receive either active 80 Hz tACS or sham (placebo) stimulation. Participants and the person delivering the stimulation do not know the group assignment. Both groups complete the same cognitive tests before and after the sessions, measuring overall cognitive status, planning, visuospatial working memory, and reaction speed. The aim is to determine whether active 80 Hz tACS improves cognitive performance more than sham stimulation.
Read the detailed description
Mild cognitive impairment (MCI) is a decline in memory and thinking skills that is greater than expected for a person's age but not severe enough to interfere substantially with daily life. Older adults with MCI are at increased risk of developing dementia, and there are currently few effective treatments for the cognitive difficulties it causes.
This study tests whether a form of non-invasive brain stimulation called transcranial alternating current stimulation (tACS) can improve thinking and memory in older women with MCI. tACS delivers a weak electrical current that oscillates at a set frequency through electrodes placed on the scalp. In this study the current oscillates at 80 Hz, a frequency in the gamma range, because gamma brain rhythms are involved in memory and attention and are known to be disrupted in MCI and Alzheimer's disease.
Thirty older women with MCI are randomly assigned to one of two groups. One group receives active 80 Hz tACS and the other receives sham (placebo) stimulation, in which the device is set up identically but no meaningful current is delivered. Participants and the person delivering the stimulation do not know which group each participant is in. Both groups complete the same set of cognitive tests before and after the stimulation sessions. The tests measure overall cognitive status, planning ability, visuospatial working memory, and reaction speed.
The aim is to determine whether active 80 Hz tACS improves cognitive performance more than sham stimulation in this population.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- transcranial electrical stimulation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial electrical stimulationDevice
Transcranial electrical stimulation (tES) is a non-invasive neuromodulation technique that applies low-intensity electrical currents to the scalp to modulate brain activity. It targets specific brain regions to influence neuronal excitability, connectivity, and plasticity, offering potential therapeutic benefits for neurological and psychiatric conditions. tES is portable, cost-effective, and generally well-tolerated, with minimal side effects such as mild tingling or itching at the stimulation site.
| Study group | Role | What they receive |
|---|---|---|
| active tACS group | Active comparator | This group receives active 80 Hz transcranial alternating current stimulation (tACS). tACS delivers a weak, low-intensity sinusoidal current that oscillates at a set frequency through electrodes placed on the scalp; here, the current oscillates at 80 Hz, in the gamma range. Participants receive 10 sessions of 30-minute stimulation up to 2 mA delivered to the prefrontal and temporoparietal brain regions Receives: Device: transcranial electrical stimulation |
| sham tACS group | Sham comparator | This group receives sham stimulation using the same device, electrode montage, and setup as the active arm. The current is ramped up over 30 seconds and then ramped down over 30 seconds, so that participants feel the same initial tingling sensation as in the active condition, but no sustained stimulation is delivered for the remainder of the session. This method allows participants to remain blind to their group assignment. Receives: Device: transcranial electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall cognitive status
The Montreal Cognitive Assessment (MoCA) is a validated screening measure of global cognitive status, scored from 0 to 30, with higher scores indicating better cognition. Change from baseline to the post-intervention assessment is compared between the active 80 Hz tACS and sham groups.
Measured: Baseline (pre-intervention), week 2 (immediately after the intervention)
Secondary outcomes (3)
Planning and problem-solving - Performance accuracy and reaction time
The Tower of London is a computerized task that assesses executive function, specifically planning and problem-solving. Higher scores indicate better planning ability. Change from baseline to the post-intervention assessment is compared between the active 80 Hz tACS and sham groups.
Measured: Baseline (pre-intervention), week 2 (immediately after the intervention)
Spatial working memory - Performance accuracy and reaction time
The Corsi Block-Tapping Test is a computerized task that assesses visuospatial short-term and working memory. Participants reproduce sequences of illuminated blocks of increasing length. Higher scores indicate greater visuospatial working memory capacity. Change from baseline to the post-intervention assessment is compared between the active 80 Hz tACS and sham groups.
Measured: Baseline (pre-intervention), week 2 (immediately after the intervention)
Cognitive Reaction time
The simple reaction time task is a computerized measure of psychomotor speed. Participants respond as quickly as possible to a stimulus that appears at unpredictable intervals. Shorter reaction times, measured in milliseconds, indicate faster psychomotor speed. Change from baseline to the post-intervention assessment is compared between the active 80 Hz tACS and sham groups
Measured: Baseline (pre-intervention), week 2 (immediately after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start2 Mar 2024
- Primary completion1 Apr 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The National Brain Mapping Laboratory (NBML)
- Sponsor type
- University, hospital or other
- Collaborators
- Mohaghegh Ardabili University, University Hospital, Aachen
- Responsible party
- Principal investigator, Mohammad Ali Salehinejad, PhD, The National Brain Mapping Laboratory (NBML)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752316
- Sponsor's protocol ID
- MAU
- Acronym
- TACS-MCI
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 80 Hz Transcranial Alternating Current Stimulation (tACS) on Cognitive Function in the Elderly With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07752316
- Acronym / sponsor ID
- TACS-MCI / MAU
- Conditions
- Mild Cognitive Impairment (MCI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The National Brain Mapping Laboratory (NBML)University, hospital or other
- Collaborators
- Mohaghegh Ardabili University, University Hospital, Aachen
- Study start
- 2 Mar 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 7 Aug 2026 (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.
Mild cognitive impairment (MCI) is a decline in memory and thinking that exceeds normal aging but does not substantially disrupt daily life, and it raises the risk of developing dementia. Effective treatments for its cognitive difficulties are few.
This study tests whether transcranial alternating current stimulation (tACS), a non-invasive method that delivers a weak oscillating electrical current through scalp electrodes, can improve thinking and memory in older women with MCI. The current oscillates at 80 Hz, a frequency in the gamma range, because gamma brain rhythms support memory and attention and are disrupted in MCI.
Thirty older women with MCI are randomly assigned to receive either active 80 Hz tACS or sham (placebo) stimulation. Participants and the person delivering the stimulation do not know the group assignment. Both groups complete the same cognitive tests before and after the sessions, measuring overall cognitive status, planning, visuospatial working memory, and reaction speed. The aim is to determine whether active 80 Hz tACS improves cognitive performance more than sham stimulation.
Detailed description
Mild cognitive impairment (MCI) is a decline in memory and thinking skills that is greater than expected for a person's age but not severe enough to interfere substantially with daily life. Older adults with MCI are at increased risk of developing dementia, and there are currently few effective treatments for the cognitive difficulties it causes.
This study tests whether a form of non-invasive brain stimulation called transcranial alternating current stimulation (tACS) can improve thinking and memory in older women with MCI. tACS delivers a weak electrical current that oscillates at a set frequency through electrodes placed on the scalp. In this study the current oscillates at 80 Hz, a frequency in the gamma range, because gamma brain rhythms are involved in memory and attention and are known to be disrupted in MCI and Alzheimer's disease.
Thirty older women with MCI are randomly assigned to one of two groups. One group receives active 80 Hz tACS and the other receives sham (placebo) stimulation, in which the device is set up identically but no meaningful current is delivered. Participants and the person delivering the stimulation do not know which group each participant is in. Both groups complete the same set of cognitive tests before and after the stimulation sessions. The tests measure overall cognitive status, planning ability, visuospatial working memory, and reaction speed.
The aim is to determine whether active 80 Hz tACS improves cognitive performance more than sham stimulation in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tACS group | Active comparator | Device: transcranial electrical stimulationThis group receives active 80 Hz transcranial alternating current stimulation (tACS). tACS delivers a weak, low-intensity sinusoidal current that oscillates at a set frequency through electrodes placed on the scalp; here, the current oscillates at 80 Hz, in the gamma range. Participants receive 10 sessions of 30-minute stimulation up to 2 mA delivered to the prefrontal and temporoparietal brain regions |
| sham tACS group | Sham comparator | Device: transcranial electrical stimulationThis group receives sham stimulation using the same device, electrode montage, and setup as the active arm. The current is ramped up over 30 seconds and then ramped down over 30 seconds, so that participants feel the same initial tingling sensation as in the active condition, but no sustained stimulation is delivered for the remainder of the session. This method allows participants to remain blind to their group assignment. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female, aged 60 to 75 years
- Diagnosis of mild cognitive impairment (MCI) established by a psychiatrist and documented in the patient's medical record
- Montreal Cognitive Assessment (MoCA) score between 16 and 22
- Written informed consent to participate in the study
- No history of Parkinson's disease, stroke, epilepsy, schizophrenia, or congenital olfactory and gustatory disorders
Key exclusion criteria (3 listed)
- Inability to tolerate the adverse effects of the stimulation
- Unwillingness to continue the sessions
- Absence from more than three intervention sessions
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 stimulationTranscranial electrical stimulation (tES) is a non-invasive neuromodulation technique that applies low-intensity electrical currents to the scalp to modulate brain activity. It targets specific brain regions to influence neuronal excitability, connectivity, and plasticity, offering potential therapeutic benefits for neurological and psychiatric conditions. tES is portable, cost-effective, and generally well-tolerated, with minimal side effects such as mild tingling or itching at the stimulation site. | Device | active tACS group, sham tACS group |
Primary outcome
Overall cognitive status
Time frame: Baseline (pre-intervention), week 2 (immediately after the intervention)
The Montreal Cognitive Assessment (MoCA) is a validated screening measure of global cognitive status, scored from 0 to 30, with higher scores indicating better cognition. Change from baseline to the post-intervention assessment is compared between the active 80 Hz tACS and sham groups.
3 secondary outcomes
Planning and problem-solving - Performance accuracy and reaction time
Time frame: Baseline (pre-intervention), week 2 (immediately after the intervention)
Spatial working memory - Performance accuracy and reaction time
Time frame: Baseline (pre-intervention), week 2 (immediately after the intervention)
Cognitive Reaction time
Time frame: Baseline (pre-intervention), week 2 (immediately after the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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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 transcranial electrical stimulation in people with Mild Cognitive Impairment (MCI), run by The National Brain Mapping Laboratory (NBML) at 1 site in Iran.
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 3 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 7 Aug 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 Iran. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall cognitive status (time frame: Baseline (pre-intervention), week 2 (immediately after the intervention)). 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 7 Aug 2026.