NCT05291208

Clinical Trial Through Combined tACS Therapy in Patients With Mild Cognitive Impairment

Status unknown Phase 2 Last updated 1 September 2023

What this trial tests

Phase 2 trial testing Combined tACS and Cognitive Training Program in Mild Cognitive Impairment in 62 participants. Status unknown.

Timeline

26 January 2022

Primary endpoint
21 September 2023

21 September 2024

Quick facts

Lead sponsor	Universidad del Desarrollo
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	62
Start date	26 January 2022
Primary completion	21 September 2023
Estimated completion	21 September 2024
Sites	1 location across Chile

Drugs / interventions tested

• Combined tACS and Cognitive Training Program
• Traditional Cognitive Training Program

Conditions studied

• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →

Sponsor

Universidad del Desarrollo — full company profile →

Who can join

60 and older, any sex, with Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aging of the population has led to an increase in the prevalence of disabling and high-cost diseases, such as dementia and Mild Cognitive Impairment (MCI). The latter can be considered a prodromal phase of some dementias and a critical stage for interventions to postpone the impairment of functionality and thus maintain a better quality of life. A cognitive function to intervene in working memory (WM) since it represents the fundamental component of executive functions and is the gateway to maintaining long-term memory. This project proposes an intervention to enhance WM in these users, combining cognitive training with non-invasive brain stimulation, specifically transcranial electrical stimulation of alternating current (tACS). This proposal arises from recent evidence showing that it is possible to increase the capacity of WM in users with MCI through cognitive training. Along with this, tACS has been proposed as a specific neuronal plasticity inducer for the oscillatory pattern required for each mental process. WM is a process particularly susceptible to being enhanced by this technique, as the underlying electrophysiological oscillatory patterns of this process are well described. Thus, tACS would act as a potentiator of the residual capacity of WM in patients with neurodegenerative diseases.

This study is a phase II randomized, double-blind clinical trial with a 3-month follow-up. The study will be of 62 participants diagnosed with MCI over 60 years from Valparaíso, Chile. Participants will receive intervention that will combine 12 cognitive training sessions with non-invasive brain stimulation, specifically tACS. Depending on the intervention group to which they will be assigned, in 8 of these sessions, participants will receive either tACS or sham stimulation. Sessions will last approximately 1 hour and take place twice a week, over six weeks. The primary outcomes will be the electroencephalographic measurements, and the secondary effects will be cognitive assessments of WM. The outcomes will be performed before, immediately after, and three months after the end of the intervention.

The outcomes of this trial will add evidence about the benefits and feasibility of an intervention that combines cognitive training with non-invasive brain stimulation. The objective is to contribute tools for optimal cognitive treatment in patients with MCI. To enhance WM capacity, postpone the impairment of functionality, and obtain a better quality of life.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Transcranial alternating current stimulation for neuropsychiatric disorders: a systematic review of treatment parameters and outcomes.
   Gholamali Nezhad F, Martin J, Tassone VK, Swiderski A, et al · · 2024 · cited 7× · PMID 39211537 · DOI 10.3389/fpsyt.2024.1419243
2. The effect of a cognitive training therapy based on stimulation of brain oscillations in patients with mild cognitive impairment in a Chilean sample: study protocol for a phase IIb, 2 × 3 mixed factorial, double-blind randomised controlled trial.
   Figueroa-Vargas A, Góngora B, Alonso MF, Ortega A, et al · · 2024 · cited 7× · PMID 38395980 · DOI 10.1186/s13063-024-07972-7
3. Individualized frequency and montage tACS to engage theta-gamma coupling and enhance working memory in mild cognitive impairment.
   Mirjalili M, Palamarchuk IS, Brooks H, Zomorrodi R, et al · · 2025 · cited 2× · PMID 40530065 · DOI 10.3389/fpsyt.2025.1565881
4. The effect of a cognitive training therapy based on stimulation of brain oscillations in patients with Mild Cognitive Impairment in a Chilean sample: study protocol for a randomised controlled trial
   Vargas AMF, Góngora B, Alonso MF, Ortega A, et al · · 2024 · DOI 10.21203/rs.3.rs-3508141/v1