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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Participants 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. |
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| Sham | Placebo Comparator | Participants 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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] | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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] |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Autonoma del Estado de Hidalgo | Pachuca | Hidalgo | 42082 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27145765 | Background | 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. | |
| 30503376 |
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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
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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.
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| Baseline (pre-intervention), post-intervention (after completion of the intensive phase, Week 5), and follow-up assessments (Weeks 8 and 12) |
| 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. |
| 31782505 | Background | 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. |
| 30395314 | Background | 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. |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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