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Cognitive Dysfunction ( MMSE < 24 )TDCSCOGSCDTRIANCT07531888

Effects of tDCS on Cognitive Function in Older Adults With Subjective Cognitive Decline: Randomized Sham-Controlled Trial

A study testing Transcranial Direct Current Stimulation in people with Cognitive Dysfunction ( MMSE < 24 ), run by Universidad Autónoma del Estado de Hidalgo at 1 site in Mexico.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This randomized, double-blind, sham-controlled clinical trial evaluates the effects of transcranial direct current stimulation (tDCS) using the Sooma Oy device on cognitive function in older adults with Subjective Cognitive Decline (SCD). Read more about this study

Who is it for?
Ages 60 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Cognitive Dysfunction ( MMSE < 24 )
What is being tested?
Transcranial Direct Current Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteMexico
Study dates
17 Apr 2026to 30 Dec 2026
Phase
Interventional
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 60 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Right-handed (for MRI purposes)
  • Age 60 to 75 years
  • 6 years or more of schooling
  • Proficiency in Spanish
  • Amnestic Mild Cognitive Impairment established by clinical examination
  • Adequate visual and auditory acuity to perform neuropsychological tests and undergo cognitive rehabilitation
Show all 9Show fewer
  • If receiving psychotropic medication, to have started it at least 12 weeks prior to the start of the study, remain at stable doses, or have discontinued it for at least 4 weeks
  • Good general health without medical or psychiatric illnesses that would interfere with the study
  • An informant capable of responding to clinimetric assessments throughout the study and willing to accompany the patient for at least 10 hours per week

Who cannot join

  • 1. Any neurological disease other than Alzheimer's disease that raises suspicion of cognitive impairment, such as Parkinson's disease, multiple infarct dementia, Huntington's disease, hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or a history of traumatic brain injury with loss of consciousness.
  • 2. Participants with a history of severe psychiatric disorders according to the DSM-5 (bipolar disorder, schizophrenia, chronic depression) or with psychotic features, agitation, or behavioral problems in the last three months that could lead to difficulties in complying with the protocol.
  • 3. History of psychoactive substance abuse and current alcohol consumption with a pattern of abuse or dependence in the last two years.
  • 4. Participants with abnormalities on a conventional electroencephalogram (paroxysmal phenomena identified by a neurophysiologist). 5. Participants with pacemakers, intracranial metallic objects or a history of brain surgery, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body.
  • 5. Participants with pacemakers, intracranial metallic objects or a history of brain surgery, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body.
  • 6. Participation in clinical studies with neuropsychological measures taken more than once a year.
  • 7. Having received prior treatment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mexico1 site
  • Universidad Autonoma del Estado de Hidalgo

    Pachuca, Hidalgo, 42082

Other trials in Mexico

About this study

Official title: Effects of Transcranial Direct Current Stimulation (tDCS) on Cognitive Function in Older Adults With Subjective Cognitive Decline: A Randomized, Double-Blind, Sham-Controlled Trial.

This randomized, double-blind, sham-controlled clinical trial evaluates the effects of transcranial direct current stimulation (tDCS) using the Sooma Oy device on cognitive function in older adults with Subjective Cognitive Decline (SCD). The study investigates changes in memory, executive function, attention, and global cognition after a structured intervention consisting of 22 intensive sessions and 8 maintenance sessions. Assessments occur at baseline, Week 4, Week 8, and Week 12.

Read the detailed description

This study uses the Sooma tDCS system (Sooma Oy, Finland) to deliver a current of 2 mA for 30 minutes per session. The anode is positioned over F3 (left dorsolateral prefrontal cortex) and the cathode over F4 (right dorsolateral prefrontal cortex), according to the international 10-20 system. Participants receive 22 intensive sessions (five days per week) followed by 8 weekly maintenance sessions. The sham condition mimics the stimulation procedure through a 30-second ramp-up and ramp-down period without sustained active stimulation.

Primary and secondary outcomes focus on changes in cognitive function, assessed using validated neuropsychological instruments.

In addition, the study includes the analysis of molecular biomarkers associated with calcium (Ca²⁺) homeostasis, as age-related changes disrupt multiple electrophysiological processes within the hippocampus. These alterations have been proposed as potential biomarkers of brain aging and are closely linked to cognitive decline. Biological samples will be obtained through buccal swabs using sterile cotton applicators from participating older adults. Total RNA will then be extracted using the TRIzol method, followed by the design of specific primer oligonucleotides and amplification using a commercial RT-PCR kit.

This clinical trial aims to generate evidence on the therapeutic utility of tDCS in individuals with Subjective Cognitive Decline, supporting early intervention strategies and contributing to the identification of molecular correlates associated with cognitive changes.

Keywords
tDCS Randomized Controlled Trial Sham-Controlled Cognitive Intervention Aging Brain
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 Direct Current StimulationDevice

    Transcranial direct current stimulation (tDCS) is administered using the Sooma tDCS system (Sooma Oy, Finland). Active stimulation consists of delivering a constant current of 2 mA for 30 minutes per session, with the anode positioned over F3 (left dorsolateral prefrontal cortex) and the cathode over F4 (right dorsolateral prefrontal cortex) according to the international 10-20 EEG system. Participants receive 22 intensive sessions delivered five days per week, followed by 8 weekly maintenance sessions.

    For the sham condition, the same electrode placement and session duration are used; however, stimulation is applied only during a 30-second ramp-up and ramp-down period, with no sustained current delivered for the remainder of the session. This procedure is designed to maintain participant and assessor blinding.

Study groups in NCT07531888
Study groupRoleWhat they receive
TreatmentExperimentalParticipants assigned to the experimental group will receive active transcranial direct current stimulation (tDCS) using the Sooma tDCS system (Sooma Oy, Finland). The intervention consists of delivering a 2 mA current for 30 minutes per session, with the anode positioned over F3 (left dorsolateral prefrontal cortex) and the cathode over F4 (right dorsolateral prefrontal cortex), according to the international 10-20 system. The stimulation protocol includes 22 intensive sessions administered five days per week, followed by 8 weekly maintenance sessions. All sessions will be conducted under established safety and monitoring guidelines for non-invasive brain stimulation.
Receives: Device: Transcranial Direct Current Stimulation
ShamPlacebo comparatorParticipants assigned to the control (sham/placebo) group will receive sham transcranial direct current stimulation (tDCS) using the Sooma tDCS system (Sooma Oy, Finland). The procedure will replicate the experimental group conditions, including electrode placement over F3 (left dorsolateral prefrontal cortex) and F4 (right dorsolateral prefrontal cortex), as well as identical session duration. However, active stimulation will be delivered only during an initial 30-second ramp-up and ramp-down period, with no sustained current administered for the remainder of the session. This approach ensures proper blinding of both participants and outcome assessors.
Receives: Device: Transcranial Direct Current Stimulation

What is being measured

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

  1. Global cognitive function

    Executive Function, Working Memory, Verbal Fluency, Episodic Memory, Planning, and Global Cognition Executive function will be assessed using the Five Digits Test (time/errors; lower = better; no fixed range). Verbal working memory will be measured with Digit Span (approx. 0-16 forward, 0-14 backward; higher = better) and visuospatial working memory with the Corsi Block-Tapping Test (span 2-9; higher = better). Verbal fluency will be assessed using phonemic fluency (letter F; no fixed range; higher = better). Episodic memory will be measured with the Hopkins Verbal Learning Test-Revised (HVLT-R; immediate recall 0-36, delayed recall 0-12; higher = better). Planning ability will be evaluated with the Tower of London (moves/time; lower = better; no fixed range). Global cognition will be assessed using the Montreal Cognitive Assessment (MoCA; 0-30; higher = better).

    [Time Frame: Baseline, Week 5, Week 8, and Week 12]

    Measured: Participants will undergo a 1-week baseline assessment, followed by a 5-week intensive intervention phase. A post-intervention assessment will be conducted at Week 6. Follow-up assessments will be performed at Weeks 10, 14, and 18. The total study durati

Secondary outcomes (1)
  1. Calcium-related molecular biomarkers (STIM and ORAI gene expression)

    Gene expression levels of STIM and ORAI will be measured from buccal swab samples using RT-PCR. Relative gene expression will be quantified (fold change). Changes in expression levels will be analyzed between groups, where increased or decreased expression reflects modulation of calcium-related pathways.

    [Time Frame: Baseline, Week 5, Week 8, and Week 12]

    Measured: Baseline (pre-intervention), post-intervention (after completion of the intensive phase, Week 5), and follow-up assessments (Weeks 8 and 12)

Timeline

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

  1. First posted15 Apr 2026
  2. Study start17 Apr 2026 (estimated)
  3. Primary completionNov 2026 (estimated)
  4. Study completion30 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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a randomized clinical trial with two parallel groups, using a double-blind design, in which an active treatment group receiving transcranial direct current stimulation (tDCS) is compared with a sham (placebo) control group. Participants are randomly assigned to each group, and blinding is maintained for both participants and outcome assessors. This design allows for rigorous control of bias and a valid evaluation of treatment efficacy.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07531888
Sponsor's protocol ID
UniversidadAEH
Acronym
TDCSCOGSCDTRIA
Status last verified
Apr 2026
First submitted
12 Feb 2026
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: This study represents the first time the research team has registered a clinical trial; therefore, the process of defining and classifying outcome measures has been carried out with particular care to ensure methodological clarity and coherence. In addition to clinical and neuropsychological outcomes, the study includes an exploratory measurement of molecular biomarkers related to calcium (Ca²⁺) homeostasis, as age-related changes disrupt multiple electrophysiological processes, particularly at the hippocampal level. These alterations have been proposed as potential biomarkers of cognitive decline. The inclusion of this measurement is complementary and exploratory in nature, and its purpose is to provide additional information that allows for a more comprehensive interpretation of the cognitive changes observed following transcranial direct current stimulation (tDCS). The collection of biological samples through buccal swabbing constitutes a non-invasive, safe, and appropriate proced

Publications

  • Dedoncker J, Brunoni AR, Baeken C, Vanderhasselt MA. The effect of the interval-between-sessions on prefrontal transcranial direct current stimulation (tDCS) on cognitive outcomes: a systematic review and meta-analysis. J Neural Transm (Vienna). 2016 Oct;123(10):1159-72. doi: 10.1007/s00702-016-1558-x. Epub 2016 May 4.

    PubMed 27145765
  • Galli G, Vadillo MA, Sirota M, Feurra M, Medvedeva A. A systematic review and meta-analysis of the effects of transcranial direct current stimulation (tDCS) on episodic memory. Brain Stimul. 2019 Mar-Apr;12(2):231-241. doi: 10.1016/j.brs.2018.11.008. Epub 2018 Nov 17.

    PubMed 30503376
  • Huo L, Zhu X, Zheng Z, Ma J, Ma Z, Gui W, Li J. Effects of Transcranial Direct Current Stimulation on Episodic Memory in Older Adults: A Meta-analysis. J Gerontol B Psychol Sci Soc Sci. 2021 Mar 14;76(4):692-702. doi: 10.1093/geronb/gbz130.

    PubMed 31782505
  • Manenti R, Sandrini M, Gobbi E, Binetti G, Cotelli M. Effects of Transcranial Direct Current Stimulation on Episodic Memory in Amnestic Mild Cognitive Impairment: A Pilot Study. J Gerontol B Psychol Sci Soc Sci. 2020 Aug 13;75(7):1403-1413. doi: 10.1093/geronb/gby134.

    PubMed 30395314

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Direct Current Stimulation in people with Cognitive Dysfunction ( MMSE < 24 ), run by Universidad Autónoma del Estado de Hidalgo at 1 site in Mexico.

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 9 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 15 Apr 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 Mexico. 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?

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?

Global cognitive function (time frame: Participants will undergo a 1-week baseline assessment, followed by a 5-week intensive intervention phase. A post-intervention assessment will be conducted at Week 6. Follow-up assessments will be performed at Weeks 10, 14, and 18. The total study durati). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07531888, which also lists 4 linked publications.

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 15 Apr 2026.

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