NCT07752316

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
Last Updated

August 7, 2026

Status Verified

August 1, 2026

Enrollment Period

1.1 years

First QC Date

August 3, 2026

Last Update Submit

August 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (pre-intervention), week 2 (immediately after the intervention)

Secondary Outcomes (3)

  • Planning and problem-solving - Performance accuracy and reaction time

    Baseline (pre-intervention), week 2 (immediately after the intervention)

  • Spatial working memory - Performance accuracy and reaction time

    Baseline (pre-intervention), week 2 (immediately after the intervention)

  • Cognitive Reaction time

    Baseline (pre-intervention), week 2 (immediately after the intervention)

Study Arms (2)

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

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.

Device: transcranial electrical stimulation

Interventions

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.

active tACS groupsham tACS group

Eligibility Criteria

Age60 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to tolerate the adverse effects of the stimulation
  • Unwillingness to continue the sessions
  • Absence from more than three intervention sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, University of Mohaghegh Ardabili

Ardabil, Iran

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal collaborator

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 7, 2026

Study Start

March 2, 2024

Primary Completion

April 1, 2025

Study Completion

October 15, 2025

Last Updated

August 7, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations