Combined tDCS and Cognitive Training in Alzheimer's

Summary

The General Objective of the study is to evaluate the short- and long-term efficacy of combining transcranial Direct Current Stimulation (tDCS) and cognitive training (CT) in patients with mild cognitive impairment and early-stage Alzheimer's disease. A randomized, double-blind, placebo-controlled design will be applied. An inter-subject design with two groups will be used: a. Active tDCS + concurrent CT and b. Sham tDCS + concurrent CT. Evaluations will be taken at pre-test, post-test, and follow-up one month later. The hypothesis comparing active and sham tDCS with concurrent CT is that, although both groups should improve due to concurrent CT, it is expected that the active tDCS group will show significantly greater improvements in post-treatment. Additionally, these improvements should be maintained in the long-term follow-up in the active tDCS group, while in the sham tDCS group, a return to baseline is expected in the follow-up measures.

Transcranial Direct Current Stimulation (tDCS): HDC stimulators (Newronika TM, Milan, Italy) will be used. For active stimulation, the current intensity will be constant at 2 mA, with a stimulation time of 20 minutes daily for 12 days, and an initial and final ramp of 30 seconds. For the placebo group, current will only be applied during the initial and final ramps to generate the sensation of active stimulation. A neoprene cap with carbon rubber electrodes and sponges soaked in saline solution (5 x 5 cm) will be used. The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC), and the cathode over the right supraorbital area (rSO).

Cognitive Training (CT): The CT will consist of 12 sessions of 50 minutes each, based on tasks involving executive functions and memory, including categorization, answering questions, short stories, problem-solving, recalling autobiographical moments, planning simple tasks, and schedule analysis.

Conditions

• Prodromal Alzheimer's Disease

Interventions

DEVICE

Transcraneal Direct Current Stimulation (tDCS)- Active

The stimulation will use a neoprene cap with carbon rubber electrodes and sponges soaked in saline solution (5x5 cm). The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC), and the cathode over the right supraorbital area (rSO). Constant current intensity of 2mA and a stimulation time of 20 minutes per day for 12 days will be applied, with an initial and final ramp of 30 seconds.

DEVICE

Transcranial Direct Current Stimulation (tDCS)- Sham

Participants assigned to the sham tDCS group will also receive 12 home-based sessions of 20 minutes each. However, to mimic the sensation of active stimulation without delivering therapeutic current, the stimulator will only apply current during the initial and final 30-second ramp periods. The device will remain on for 20 minutes, but no current will be applied after the first ramp, simulating an active procedure without physiological effect.

BEHAVIORAL

Cognitive Training (CT)

All participants will complete 12 home-based cognitive training sessions, each lasting 50 minutes. The training will include structured tasks focused on executive function and memory, such as categorization, problem-solving, autobiographical recall, planning, and schedule analysis. Instructions will be provided at the start of each session, and participants will work independently or with caregiver support.

Sponsors & Collaborators

• University of Valencia

  lead OTHER

Principal Investigators

• Juan C Melendez, PhD · University of Valencia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-04

Primary Completion

2025-09-15

Completion

2026-12-31

Countries

• Spain

Study Locations