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ENROLLING BY INVITATION

NCT07531888

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

Sponsor: Universidad Autónoma del Estado de Hidalgo

View on ClinicalTrials.gov

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). 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.

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.

Key Details

Gender

All

Age Range

60 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04-17

Completion Date

2026-12-30

Last Updated

2026-04-15

Healthy Volunteers

Yes

Conditions

Cognitive Dysfunction ( MMSE < 24 )

Interventions

DEVICE

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 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.

Inclusion Criteria: 1. Right-handed (for MRI purposes) 2. Age 60 to 75 years 3. 6 years or more of schooling 4. Proficiency in Spanish 5. Amnestic Mild Cognitive Impairment established by clinical examination 6. Adequate visual and auditory acuity to perform neuropsychological tests and undergo cognitive rehabilitation 7. 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 8. Good general health without medical or psychiatric illnesses that would interfere with the study 9. An informant capable of responding to clinimetric assessments throughout the study and willing to accompany the patient for at least 10 hours per week 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.

Locations (1)

Universidad Autonoma del Estado de Hidalgo

Pachuca, Hidalgo, Mexico