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Sponsor: University of Valencia
Conditions: Prodromal Alzheimer's Disease
Interventions: Transcraneal Direct Current Stimulation (tDCS)- Active, Transcranial Direct Current Stimulation (tDCS)- Sham, Cognitive Training (CT)
Countries: Spain
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 due to Alzheimer's disease. A randomized, single-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 partial loss of gains is expected at follow-up. 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 10 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 10 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.
Sex: ALL
Age: 60 Years to 90 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Participants were eligible if they met criteria for mild cognitive impairment due to Alzheimer's disease (MCI due to AD), defined as a score ≥ 23 on the Mini-Mental State Examination (MMSE) and classification at Stage 3 on the Global Deterioration Scale (GDS). Exclusion criteria included contraindications to transcranial direct current stimulation (tDCS), such as intracranial metal implants or intracranial hypertension, as well as the presence of significant cerebrovascular disease or severe psychiatric symptoms.
- Valencia, Valencia, Spain