Effects of tDCS on Cognitive Function in Older Adults With Subjective Cognitive Decline: Randomized Sham-Controlled Trial
NCT07531888 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-04-15
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.
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.
Sponsors & Collaborators
-
Universidad Autónoma del Estado de Hidalgo
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-04-17
- Primary Completion
- 2026-11-30
- Completion
- 2026-12-30
Countries
- Mexico
Study Locations
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