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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Transcranial Direct Current Stimulation
  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 s

Первичные конечные точки

• Global cognitive function [Срок оценки: 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]

Вторичные конечные точки (1)

• Calcium-related molecular biomarkers (STIM and ORAI gene expression) [Срок оценки: Baseline (pre-intervention), post-intervention (after completion of the intensive phase, Week 5), and follow-up assessments (Weeks 8 and 12)]

Критерии участия

Критерии включения

• 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
• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

• Universidad Autonoma del Estado de Hidalgo — Pachuca

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 30395314

Идентификаторы

NCT: NCT07531888 · UniversidadAEH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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